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Journal articles on the topic 'ICH Q2 (R1); Recovery'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

B, Deshmukh S., Wagh P. A, Yadav S. S, and Mane M. B. "Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 03 (2024): 1599–603. http://dx.doi.org/10.25258/ijddt.14.3.49.

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Vildagliptin (VD) and Dapagliflozin (DP) were determined simultaneously by RP-HPLC using an ultraviolet (UV) detector, a Hypersil Gold C18 (250 × 4.6 mm) column, 5 µm and a mobile phase of acetonitrile: water (adjusted with O-Phosphoric acid to pH 3) in ratio 40: 60% v/v. The estimation wavelength was chosen to be 213 nm. VD and DP were shown to have retention times of 2.9 and 8.3 minutes, respectively. Q2 (R1) ICH guidelines were followed during the validation process. VD and DP correlation coefficient R2 values are 0.9993 and 0.999, respectively. While DP’s linearity range is 1 to 6 µg/mL, V

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K, Swamy Sekhar, Venkata kishore Ch, Tejeswara Rao V, and Raghu Babu K. "HPLC method for the development and validation of busulfan in pharmaceutical formulation." GSC Advanced Research and Reviews 6, no. 3 (2021): 136–42. https://doi.org/10.5281/zenodo.4644190.

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A validated HPLC method was developed for the determination of Busulfan (BUS) in pharmaceutical formulation.It is a new simple, accurate, precise and reproducible HPLC method has been developed for the estimation of Busulfan (1,4-butanediol dimethanesulfonate) in its inject able dosage.The method developed in High Performance Liquid Chromatographic method using suitable column (YMC Pack ODS-A (150 x 4.6) mm, 3µm). All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.The method was validated as per the ICH

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3

Kumar, Sunil, and Bigan Ram. "Analytical method development and validation of L-Carnitine L-Tartarate in Pharmaceutical Dosage forms (Multivitamin tablets) using non aqueous titration." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 588–90. http://dx.doi.org/10.22270/jddt.v9i5.3591.

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The Non aqueous titration method was developed for quantitave analysis of L- Carnitine L-Tartarate in multivitamin tablets. The Non aqueous titration method was carried out using 0.1 N Perchloric acids. The present analytical method was validated according to ICH guidelines (ICH,Q2(R1)). The calibration curve was found to linear with correlation coefficient (r2=0.99995), Bias (-0.35) in the range of 50 to 150 % of standard solution. The precision and recovery were determined and all the parameter value found within acceptance limit. The value for both method and intermediate precision were fou

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4

T., S. Kamble. "High Performance Thin Layer Chromatography: Method Development and Validation for Estimating the Gallic Acid from Syzygium Cumini Seeds." International Journal of Pharmacy and Biological Sciences (IJPBS) 13, no. 3 (2023): 191–200. https://doi.org/10.5281/zenodo.10648678.

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AbstractIn the current research work, an effective, efficient, exact, easy-to-follow, and trustworthy method was developed for the estimation of gallic acid content from Jamun seed powder. In this research, HPTLC technique is used for analysis along with other quality control test parameters. The preliminary studies by virtue of solubility studies, FT-IR spectroscopy, melting point determination, etc. Working wavelength was determined by UV-Visible spectroscopy. The analytical method development was done for gallic acid estimation in Jamun seed powder, using HPTLC following its validation usin

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Banothu, Bhadru* Tadikonda Rama Rao Arukala Bhavani. "Stability Indicating Analytical Method Development And Validation Of Carbamazepine Using UV Spectroscopy." International Journal in Pharmaceutical Sciences 2, no. 9 (2024): 1374–80. https://doi.org/10.5281/zenodo.13851427.

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A novel Spectrophotometric method for quantifying carbamazepine in pharmaceuticals has been developed and validated per ICH Q2 (R1) guidelines. The maximum absorption wavelength was identified at 285 nm in a 0.1N NaOH solution, with a regression coefficient of 0.999, confirming adherence to Beer's Law within a 2–10 μg/ml concentration range. Calibration curves demonstrated linearity, and quality control standards showed accuracy, precision, and robustness, with recovery percentages between 99.2% and 100.8%. The method exhibited low relative standard deviation (RSD) values, with intra-

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Mangal, B. Gahandule* Shanker M. Dhobale1. "ESTIMATION OF HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORMS BY AREA UNDER CURVE SPECTROPHOTOMETRIC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7420–25. https://doi.org/10.5281/zenodo.1006947.

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A simple, accurate and precise area under curve method was developed for spectrophotometric estimation of hydrochlorothiazide in pure and tablet dosage forms. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of hydrochlorothiazide was between 260 to 280 nm. The method represented regression coefficient (R2 = 0.999) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the hydrochlorothi

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7

Gaikwad, Pranjal, and Vijaya Barge. "Analytical Method Development and Validation of RP-HPLC Method for Estimation of Favipiravir in Bulk and Pharmaceutical dosage form." Journal of Neonatal Surgery 14, no. 32S (2025): 4520–29. https://doi.org/10.63682/jns.v14i32s.8145.

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Objective: To develop and validate a simple, accurate, and cost-effective RP-HPLC method for the estimation of Favipiravir in bulk and pharmaceutical dosage forms. Methods: An RP-HPLC method was developed using a C18 column with methanol:water (35:65, v/v) as the mobile phase, pH 3.0, flow rate 0.8 mL/min, and UV detection at 225 nm. The method was validated as per ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. Forced degradation studies were conducted as per ICH Q1A(R2). Results: Favipiravir showed a retention time of 6.62 min. The method was

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M., M. Eswarudu* P. Srinivasa Babu P. Siva Krishna G. Sneha Latha N. Anusha M. S. K. Mounika and N. Punna Reddy. "METHOD DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF DARUNAVIR IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2230–37. https://doi.org/10.5281/zenodo.1215687.

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Two simple, precise and economical UV Spectrophotometric methods have been developed for the estimation of Darunavir ethanolate (DRV) in bulk and its pharmaceutical dosage form. Two methods were developed based on measurement of absorption at maximum wavelengths, for Method Ⅰ 272.1 nm and Method ⅠⅠ 272.4 nm. Linearity for detector response was observed in the concentration range of 2-10 μg/ml for the both methods. The developed methods were validated with respect to linearity, accuracy (recovery), precision and specificity. The accuracy of the methods was assessed by recovery studies and wa

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K. Koradia, Shailesh, Dhwani R. Patel, Prachi A. Rana, Binny A. Rudani, and Unnati S. Chaudhari. "SPECTROPHOTOMETRIC DETERMINATION OF ANTINEOPLASTIC DRUG GEFITINIB IN TABLET DOSAGE FORM USING INORGANIC SOLVENT." Indian Drugs 59, no. 12 (2022): 79–81. http://dx.doi.org/10.53879/id.59.12.13081.

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In the present research work, a simple, accurate and precise spectrophotometric method has been developed for the determination of gefitinib in bulk and its tablets dosage form. Gefitinib was dissolved in 0.1 N hydrochloric acid and absorbance was measured at 252.0 nm. The calibration curve obeyed Beer’s law in the concentration range of 3-15 µg mL-1 with correlation co-efficient of 0.9989. The detection limits and quantitation limits were found to be 0.69 µg mL-1 and 2.08 µg mL-1, respectively. The recovery ranged between 98.00 and 101.89 %. The validation parameters such as accuracy, precisi

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Mali, Rushikesh, and Tabassum Khan. "ANALYTICAL UV SPECTROSCOPY METHOD DEVELOPMENT AND VALIDATION STUDIES FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND QUERCETIN." INDIAN DRUGS 60, no. 11 (2023): 82–87. http://dx.doi.org/10.53879/id.60.11.14088.

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In the current investigation, we have designed and assessed a simple and swift analytical approach employing UV spectroscopy for the simultaneous quantification of the analytes metformin and quercetin with excellent precision and accuracy. The wavelengths of interest are the wavelengths at which both the drugs show maximum absorbance: 233 nm for metformin and 256 nm for quercetin. Linearity study, conducted in methanol and phosphate buffer, yielded a correlation coefficient (r2 ) of 0.99. The validation study for the developed method was conducted in accordance with ICH Q2 R1 guidelines. The p

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Bagad, Kunal S., Kunal Bacchao, Shashikant B. Bagade, Rakesh D. Amrutkar, and Dipak D. Patil. "RP-HPLC Estimation of Clobetasol Propionate and Salicylic Acid using Quality by Design Approach." Biosciences Biotechnology Research Asia 21, no. 1 (2024): 283–94. http://dx.doi.org/10.13005/bbra/3225.

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ABSTRACT: The RP-HPLC method for CLOP and SA estimation from bulk and pharmaceutical dosage from has been developed and validated. For analytical methods to be robust, current ICH guidelines, Q8 to Q11 were suggested use of analytical quality by design (AQbD) includes adoption of current systematic approaches. The proposed method was optimized and developed using Taguchi orthogonal design. The RP-HPLC method parameters were optimized by box- Behnken design. The stationary phase used C18 Princeton column (150mm × 4.6mm × 5µm) with acetonitrile: 0.05M phosphate buffer (pH 2.5, adjustment with by

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Gandhi, Santosh V., and Smruti C. Shinde. "CHEMOMETRIC ASSISTED UV SPECTROPHOTOMETRIC METHOD FOR QUANTIFICATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE." INDIAN DRUGS 60, no. 09 (2023): 93–99. http://dx.doi.org/10.53879/id.60.09.13152.

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The aim of this study was to verify the ability of the UV spectrophotometric method for the simultaneous determination of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form using the principal Component Regression (pCR) and partial Least Squares (pLS) multivariate calibration methods. Double beam UV-Vis spectrophotometer (Jasco V-730) with 1 cm quartz cell with 1 nm data interval and scanning speed of 400 nm min -1 was used in the study. the optimized wavelength range selected was 225-275 nm. the data obtained was processed using Unscrambler X (10.5) (64bit) software. The de

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Saboo, Kritika R., Rohit R. Ghadge, Dhanashree P. Sanap, and Sneha A. Agrawal. "ESTABLISHMENT AND AUTHENTICATION OF A UV SPECTROPHOTOMETRIC APPROACH FOR MEASURING EMBELIN CONTENT IN BULK AND FORMULATED SAMPLE." INDIAN DRUGS 61, no. 02 (2024): 92–93. http://dx.doi.org/10.53879/id.61.02.14489.

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A UV-spectrophotometric method for the estimation of embelin isolated from Embelia ribes berries as per ICH guidelines Q2 (R1) was developed. It is simple, quick, accurate, and affordable. The wavelength of embelin was found to be 294.3 nm; and was linear in the concentration range 2-12 μg mL-1 with 0.997 correlation coefficient. The method was applied to pharmaceutical formulation and the drug estimated was found to be 97.99 % and was in good agreement with the label claim. The accuracy of the method was performed at three different levels, between 80 to 120 %; with % recovery obtained 98.54

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14

Kansara, Devansh, Usmangani K. Chhalotiya, Hetaben M. Kachhiya, and Ishita Patel. "Development of TLC method for simultaneous estimation of novel combination of amlodipine besylate, rosuvastatin calcium, and fimasartan potassium in synthetic mixture." Journal of Chemical Metrology 14, no. 2 (2020): 142–52. http://dx.doi.org/10.25135/jcm.45.20.07.1744.

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An accurate, sensitive, robust and precise high performance thin layer liquid chromatography method was developed based on ICH Q2 (R1) guidelines for estimation of novel combination of Amlodipine besylate, Rosuvastatin calcium and Fimasartan potassium in bulk and its synthetic mixture. Pre-coated silica gel aluminum plate 60 F254 was selected as the stationary phase and n-hexane, n-butanol, methanol, and Glacial Acetic Acid (5.7:2:2.3:0.1, v/v/v/v) was selected as mobile phase. All three drugs showing appreciable absorbance at the common wavelength of 242 nm were selected for quantification of

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Ghante, Minal, Pooja Siddheshware, Vidhya Bhusari, Sanjay Sawant, Vasundhara Sawant, and Preeti Kulkarni. "STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ELIGLUSTAT TARTRATE." Indian Drugs 59, no. 04 (2022): 57–59. http://dx.doi.org/10.53879/id.59.04.12344.

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For determination of eliglustat tartrate, a new, specific, simple, accurate (recovery) and precise stability indicating HPLC method has been developed and validated according to ICH Q2(R1) guidelines. The HPLC method was developed using acetonitrile: 0.1 % orthophosphoric acid 40:60 (V/V) as mobile phase, with pH of mobile phase adjusted to 3.0. The column used was HiQSil C-18 (250 mm x 4.6 mm, 5 μm) as stationary phase at a flow rate of 0.7 mL min-1. Retention time for eliglustat tartarate was found to be 5.9 min. The eluted compounds were detected using a PDA detector. The drug was subjected

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Ferdowsy Koly, Sabiha, Shirajum Munira, Sonia Zaman, Saimon Shahriar, Shah Amran, and Abu Asad Chowdhury. "Development and Validation of a UV-spectroscopic Method for the Analysis of Black Plum in Marketed Preparations Using Ethanol as a Solvent." Biomedical and Pharmacology Journal 15, no. 1 (2022): 157–64. http://dx.doi.org/10.13005/bpj/2351.

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Herbal drugs are composed of single or several types of medicinal plants with additives. This type of preparations is gaining a wide range of popularity among a large a number of people throughout the world. With the increase of usage, it is necessary to maintain the quality of these drug preparations. Therefore, analytical approaches for their intended use in drug quality evaluation need to be validated. Our aim was to develop simple, rapid, selective, precise and economical UV-spectroscopic method for the quality control of black plum containing herbal preparation in different marketed formu

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Dudhrejiya, Ashvin, Ashok Patel, Jayant Chavda, Dhruvanshi Gol, and Priyal Koli. "Spectrophotometric simultaneous determination of efonidipine hydrochloride ethanolate and telmisartan in synthetic mixture by first order derivative method." Journal of medical pharmaceutical and allied sciences 11, no. 2 (2022): 4547–51. http://dx.doi.org/10.55522/jmpas.v11i2.2427.

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The established method represents the development and validation of a straight forward, precise, accurate, specific and reproducible method for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Telmisartan in synthetic mixture. First order derivative of the overlay spectra was used for quantification of both drugs. This method involving the determination of both drugs at their respective zero crossing point working wavelength was observed 231.00 nm (Zero crossing point of Telmisartan) for Efonidipine hydrochloride ethanolate and 238.60 nm (Zero crossing point of Efonidipi

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Renuka, G., R. Kiran Joythi, Mahesh M, O. Sreenivasa Krishna, and S. Nandini. "A reliable RP HPLC analytical approach for the quantification of Levonorgestrel and Ethinylestradiol in formulated products." Future Journal of Pharmaceuticals and Health Sciences 5, no. 2 (2024): 97–105. https://doi.org/10.26452/fjphs.v5i2.735.

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This study presents a reliable RP HPLC analytical approach for the simultaneous quantification of levonorgestrel and ethinylestradiol in formulated products. The proposed method involves the use of a reverse-phase high-performance liquid chromatography (HPLC) by using Inertsil ODS C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (Ph was adjusted withorthophosphoric acid), detection wavelength was 260nm. Theretentiontimeswerefoundtobe3.602 minsand5.148mins.The% purity of Levonorgestrel and Ethinylestradiol was found to be

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Praveen, Kumar Dasari* Kumar Raja Jayavaraupu Sk. Sushma Parveen. "Analytical Method Development And Validation For The Simultaneous Estimation Of Aluminium Hydroxide And Simethicone By RP-HPLC Method." International Journal in Pharmaceutical Sciences 2, no. 3 (2024): 1115–24. https://doi.org/10.5281/zenodo.10886840.

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In the present research, a new rapid, economical, simple, isocratic and cost-effective reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantification of simultaneous Aluminium hydroxide and Simethicone. The chromatographic parameters were successfully developed for the separation of Aluminium hydroxide and Simethicone by employing Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 2

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B.R, Shyam Raj Naik, Mahesh M, Kiran Joythi R, and Subhahan B.S. "Method Development and Validation for Rapid Simultaneous Estimation of Tinidazole and Diloxanide Furoate in Pharmaceutical Dosage Form by Using RP-HPLC." International Journal of Chemistry and Pharmaceutical Sciences 13, no. 1 (2025): 16–22. https://doi.org/10.30904/j.ijcps.2025.4787.

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A new method was established for simultaneous estimation of Tinidazole and Diloxanide furoate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tinidazole and Diloxanide furoate by using Thermosil RP C18 (4.5×100 mm) 5.0µm, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol. The retention times were found to be 2.408mins and 3.016mins. The % purity of Tinidazole and Diloxanide furoate was found to be 99.24% and 101.27% respectively. The system suitability parameters for Tinidazole and Diloxanide furoate such as theoretical plate

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Dhobale, Shankar, Vaibhav Narad, and Dushyant Gaikwad. "Estimation of Lovastatin in Pharmaceutical Formulation by Area under Curve Spectrophotometric Method." IRA-International Journal of Applied Sciences (ISSN 2455-4499) 6, no. 3 (2017): 86. http://dx.doi.org/10.21013/jas.v6.n3.p3.

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<div><p><em>Development of an accurate, simple and cost effective UV spectrophotometric method for estimation of Lovastatin was the aim of present study. This work was based upon an area under curve method i.e. “concentration of the component of interest is directly proportional to the area under two points on the mixture spectra”. The UV spectrum between 238-258 nm was selected and the validation was carried out as per ICH guideline, Q2 (R1). This method obeyed Beer’s Lamberts Law over the concentration range of 5-25μg /ml. The value of correlation coefficient was 0.9988. Th

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Jani, Shivani, Rashmi Shukla, Pinak Patel, Binny Mehta, and Krunal Detholia. "Quantitative estimation of sitagliptin and dapagliflozin propanediol monohydrate in synthetic mixture using 1 order derivative spectroscopy simultaneous spectrophotometric analysis." International Journal of Pharmaceutical Chemistry and Analysis 9, no. 1 (2022): 28–34. http://dx.doi.org/10.18231/j.ijpca.2022.005.

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Current research paper describes highly specific and reproducible 1 order derivative spectroscopic method for quantitative analysis of Sitagliptin which is a DPP4 inhibitors and Dapagliflozin which is SGLT2 inhibitors from its synthetic mixture. Both drugs are from Anti Diabetics class. Present analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. Quantification of Sitagliptin was carried out at zero cross over point of Dapagliflozin that is 275 nm and for Dapagliflozin, it was achieved at 232 nm which

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Corte, Augusto Cesar, and Leticia Lenz Sfair. "Development and validation of analytical methodology for quality evaluation of Tibolone in capsule pharmaceutical form through UV spectrophotometry." Drug Analytical Research 3, no. 2 (2019): 7–11. http://dx.doi.org/10.22456/2527-2616.96926.

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Tibolone is a drug used as a hormonal repository and is very important due to its characteristic of helping to reduce the symptoms triggered by the hormonal alteration during the climacteric period. Although widely used, the Brazilian Pharmacopoeia does not have any information about this hormone. In the literature, only studies with methodologies using high performance liquid chromatography for drug quantification were found. Thus, this study aimed to develop and validate analytical method using UV spectrophotometry for quality control of Tibolone in capsule pharmaceutical form. The present s

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Prasad, N. Nukendra, R. Venkata Nadh, and N. Srinivasu. "Validated HPLC Method for Assay and Content Uniformity Testing of Roflumilast in Blend and Tablets." Asian Journal of Chemistry 32, no. 6 (2020): 1279–85. http://dx.doi.org/10.14233/ajchem.2020.22373.

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Roflumilast is a selective enzyme inhibitor of phosphodiesterase-4. This drug is recommended for treatment of patients suffering from chronic-obstructive-pulmonary-disease with chronic-bronchitis. Roflumilast is not official in pharmacopoeia and the reported methods are having high chromatographic run times. A short run time HPLC method was developed for assay and content uniformity testing to determine the roflumilast in blend and tablets. The mobile phase consists of 10 mM sodium dihydrogen phosphate monohydrate buffer and acetonitrile in the ratio of 45:55 v/v. The HPLC method was developed

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Chauhan, Vikas, Parul Grover, and Kandasamy Nagarajan. "GREEN SOLVENT ASSISTED UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF PIROXICAM IN BULK AND TABLET DOSAGE FORM." INDIAN DRUGS 62, no. 01 (2025): 74–75. https://doi.org/10.53879/id.62.01.14495.

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A precise, simple, economical and accurate UV spectroscopy-assisted method has been developed to estimate piroxicam (PRXM) in pure API and tablet dosage form. The absorbance maxima of PRXM were found at 357nm λmax using water (H2O) and methanol (MeOH) in a ratio of 40:60 V/V as a solvent. For concentrations between 2 μg mL-1 - 12 μg mL-1, the procedure adheres to Beer's law with an R2 value of 0.9992, the linearity was found in the calibration curve between absorbance and concentration in accordance with the line equation y=0.0508x+0.0085. The LOD and LOQ were found to be 0.90 µg mL-1 and 2.74

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Sakshi, B. Tarle* Smita. S. Aher Durga. B. Zade Dr. Rushikesh. S. Bachhav. "An Approach To Bioanalytical Method Development And Validation: A Review." International Journal of Pharmaceutical Sciences 2, no. 7 (2024): 382–93. https://doi.org/10.5281/zenodo.12671255.

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The execution of all the steps necessary to show that a specific technique employed for the quantitative measurement of analytes in a given biological matrix (such as blood, plasma, serum, or urine) is reliable and consistent for the intended application. Three categories of bioanalytical validation exist: cross-validation, partial validation, and full validation. Accuracy, precision, linearity, selectivity and specificity, limit of detection, limit of quantitation, standard curve (calibration curve), recovery, stability, robustness, and ruggedness are among the important bioanalytical techniq

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Tejas, Ghadge* Pranay Ghisare Siddharth Dumbre Nikhil Mane Sahil Deshmukh Om Karande. "Analytical Method Development and Validation of Drospirenone by UV-Vis Spectroscopy in Accordance with ICH Guidelines." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 333–41. https://doi.org/10.5281/zenodo.15333630.

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This study presents the development and validation of a UV-Visible spectrophotometric method for the estimation of Drospirenone in pharmaceutical formulations. Drospirenone, a synthetic progestin, was found to be freely soluble in ethanol, which was selected as the solvent due to its green chemistry profile. The absorption maximum (λmax) was observed at 274 nm. A linear calibration curve was established over the concentration range of 3–15 µg/mL, exhibiting excellent linearity with a correlation coefficient (r²) of 0.9999. The method demonstrated high sensitivity, with

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Kaur, Jaspreet, Daljit Kaur, and Sukhmeet Singh. "DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS." Asian Journal of Pharmaceutical and Clinical Research 11, no. 9 (2018): 115. http://dx.doi.org/10.22159/ajpcr.2018.v11i9.25550.

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Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as a

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Srikanth, Banothu, Badi Pavani, Ollepu Keerthana, et al. "Method Development and Validation for Quantitative Estimation of Bortezomib in its Bulk and Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 13, no. 6 (2023): 145–51. http://dx.doi.org/10.22270/jddt.v13i6.5889.

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A new method was established for estimation of Bortezomib by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Bortezomib by using Phenomenex Luna C18 column 250x4.6mm 5µm, flow rate was 1.0 ml/min, mobile phase ratio was Acetonitrile : 0.1% formic acid (50: 50 v/v),detection wavelength was 280 nm. The retention time was found to be 5.3 mins. The % purity of Bortezomib was found to be 100.443% respectively. The system suitability parameters for Bortezomib such as theoretical plates and tailing factor were found to be more than 2000 and less than 2

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N., Anjaneyulu* R. Naga Kishore M. Ravi Kumar and D. Anil Naik. "DEVELOPMENT AND VALIDATION OF A RP- HPLC METHOD FOR THE BIO-ANALYSIS OF OXCARBAZEPINE IN RAT PLASMA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 12 (2018): 16786–96. https://doi.org/10.5281/zenodo.2525362.

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<em>A new plan was fixed for estimation of Oxcarbazepine by RP-HPLC method. The chromatographic actions continue strongly grow for the break of Oxcarbazepine by applying Agilent C18 column (4.6×150mm) 5µ, flow rate was 1.0 ml/min, mobile phase ratio was Di- potassium hydrogen phosphate: ACN (70:30% v/v) detection wavelength was 593nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The confinements times continue begin to be 2.954mins. The % pureness containing Oxcarbazepine was begin to be 99.87%

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Nandini, S., R. Kiran Joythi, Mahesh M, G. Renuka, and O. Sreenivasakrishna. "Quantitative RP HPLC analysis of rosuvastatin and fenofibrate development validation and applications in formulations." Future Journal of Pharmaceuticals and Health Sciences 5, no. 2 (2025): 89–96. https://doi.org/10.26452/fjphs.v5i2.734.

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A novel technique for the simultaneous measurement of fenofibrate and rosuvastatin using the RP-HPLC method was developed. The Agilent C18 (4.6 x 150mm, 5m) column was used to successfully create the chromatographic conditions for the separation of rosuvastatin and fenofibrate. The mobile phase ratio was Methanol: Phosphate buffer PH 3 [70: 30, v / v] (pH was adjusted with orthophosphoric acid), and the detection wavelength was 255 nm. The results showed that the retention times were 2.972 and 3.548 minutes, respectively. Rosuvastatin and fenofibrate were discovered to have purity percentages

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Kommana Swathi, T.K.V. Kesava Rao, and Cheepurupalli Prasad. "A new analytical method development and validation for estimation of cefp odoxime, azithromycin in bulk and tablet by rp-hplc." International Journal of Pharmaceuticals and Health Care Research 12, no. 4 (2024): 393–401. https://doi.org/10.61096/ijphr.v12.iss4.2024.393-401.

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Analytical Method Development and Validation for Azithromycin and Cefpodoxime in bulk and Combine Dosage Form by RP-HPLC, New method was established for simultaneous estimation of Azithromycin and Cefpodoxime by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Azithromycin and Cefpodoxime by using Symmetry ODS C18 (4.6mm×250mm, 5µm) particle size, flow rate was 1.0 ml/min, mobile phase ratio was (70:30 v/v). The system suitability parameters for Azithromycin and Cefpodoxime such as theoretical plates and tailing factor were found to be 5387, 0.97

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J, Chiranjeevi, and Mahesh M. "Development of a Robust RP-HPLC Method for the Analysis of Ofloxacin and Nitazoxanide in Fixed-Dose Combination Products." Journal of Pharmaceutical and Biomedical Analysis Letters 13, no. 1 (2025): 07–13. https://doi.org/10.30904/j.jpbmal.2025.4795.

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A new method was established for simultaneous estimation of Ofloxacin and Nitazoxanide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Ofloxacin and Nitazoxanide by using Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wavelength was 255nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.399mins and 3.907mins. The % purity of Oflo

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Ghante, Minal R., Akash C. Masale, Supriya G. Jagtap, Sanjay D. Sawant, and Vandana S. Nikam. "SIMPLE, COST EFFECTIVE UV-VIS METHOD FOR ESTIMATION OF ELVITEGRAVIR (EVG) IN PURE AND DOSAGE FORM BY QBD APPROACH AND IN PRESENCE OF MAMMALIAN PLASMA." INDIAN DRUGS 57, no. 01 (2020): 51–58. http://dx.doi.org/10.53879/id.57.01.11738.

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A simple, cost effective, UV-VIS spectrophotometric method for analysis of elvitegravir (EVG) in the presence of plasma was developed to facilitate the assessment of clinical samples or as a routine alternative tool in drug quality control laboratories for quantitative estimation of EVG. The present work delineates the estimation of EVG in 50μl of rat plasma that is directly dissolved in dimethyl sulfoxide (DMSO) and subjected to analysis. Firstly, estimation of EVG in pure and dosage form was developed and validated using analytical quality by design (QbD) as per ICH Q2 (R1), Q8 (R2) guidelin

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35

Jhansi, T. Naga, D. Pavan Kumar, Nagaraju Rajana, D. Jayadeep Kumar, and G. Nageswara Rao. "Reverse Phase Chiral HPLC Method for Enantiomeric Excess Determination of 2-Aminobutanamide." Asian Journal of Chemistry 32, no. 1 (2019): 69–72. http://dx.doi.org/10.14233/ajchem.2020.22282.

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A reverse phase chiral HPLC method was developed for the determination of (R)-2-aminobutanamide isomer content in (S)-2-amino-butanamide key starting material for levetiracetam drug substance by using a CROWNPAK CR (+) column. Perchloric acid solution (0.05 %) was used as mobile phase and the flow rate was finalized as 0.3 mL/min. UV detection wavelength was 200 nm and column temperature was set as 15 ºC. The limit of detection and limit of quantification were 0.0002 mg/mL and 0.0005 mg/mL, respectively. The linearity calibration curve of (R)-2-aminobutanamide was shown good from the range of

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36

Kola, Hephzibah, and Sangeetha Shanmugasundaram. "Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies." Pharmacia 70, no. 1 (2023): 27–37. http://dx.doi.org/10.3897/pharmacia.70.e95099.

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Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title an

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Akter, Halima, Joy Chandra Rajbangshi, Omar Faruk, Diponkor Kumar Shill, and Abu Shara Shamsur Rouf. "Development and Validation of RP-HPLC Method for Routine Analysis of Osimertinib." Bangladesh Pharmaceutical Journal 27, no. 1 (2024): 85–91. http://dx.doi.org/10.3329/bpj.v27i1.71158.

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Osimertinib is a newly approved treatment line for the non-small cell lung carcinoma actively caused by mutation in EGFR and T790M. The present study was targeted to originate a validated method for the qualification as well as quantification of osimertinib through RP-HPLC in bulk and its pharmaceutical formulation. The mobile phase, 65% triethylamine buffer (pH 2.5) and 35% acetonitrile (v/v) was run through a prontosil column (C18, 4.6×150 mm i.d., 3.5 μm particle size) at a flow rate of 0.7 ml/min. A PDA plus detector was used to scan the absorbance over 210 to 360 nm. Validation study perf

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Kola, Hephzibah, and Sangeetha Shanmugasundaram. "Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies." Pharmacia 70, no. (1) (2023): 27–37. https://doi.org/10.3897/pharmacia.70.e95099.

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Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title an

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Chennupati, V. Suresh. "Method Development and Validation for the Quantitative Determination of Vericiguat in Bulk Form and Marketed Pharmaceutical Dosage Forms by using RP-HPLC." International Journal of Pharmacy and Biological Sciences (IJPBS) 14, no. 2 (2024): 89–98. https://doi.org/10.5281/zenodo.12790508.

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AbstractThe aim of the present study is to develop simple, precise, and accurate methods for quantitative estimation of Vericiguat in bulk form and marketed pharmaceutical tablet dosage form. The method was achieved on Symmetry C18 ODS (4.6mm×250mm) 5μm particle size column with mobile phase containing composition of Acetonitrile and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70v/v at a flow rate 1.0ml/min with detection wavelength at 246nm. The linearity was obtained in the concentration range of 6-14 μg/ml for Vericiguat. The suitability of this method was proved by vali

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Shah, Priyangi, Meghana Patel, Manish Nandpal, et al. "Development and validation of a spectrofluorophotometric method for berberine hydrochloride quantification in diverse matrices." Journal of Research in Pharmacy 29, no. 3 (2024): 1274–83. https://doi.org/10.12991/jrespharm.1710276.

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Berberine hydrochloride (BHC), a key isoquinoline alkaloid from the Berberis genus, is gaining prominence for its diverse pharmacological properties. The goal was to devise rapid and sensitive spectrofluorophotometric methods (Analytical and Bioanalytical) for precise BHC estimation in varied matrices, addressing crucial needs in pharmaceutical and biomedical research.Utilizing a luminescence spectrometer (Perkin Elmer, UK), BHC was detected with 1M Methanolic H2SO4, at excitation and emission wavelength of 350 nm, and 530 nm respectively. BHC extraction from spiked human plasma employed a pro

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Krushi, Dadhaniya* Ayushi Patel Jayesh Kamble Kenil Patel Mansi Barot Megha Patil Dr. Vikram M. Pandya. "Green Solvent Assisted UV–Spectrophotometric Method for Estimation of Ranolazine in Bulk and Pharmaceutical Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 6 (2025): 969–77. https://doi.org/10.5281/zenodo.15601651.

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A green solvent-assisted UV-spectrophotometric method has been developed and validated for the estimation of ranolazine in bulk and pharmaceutical dosage forms using isopropyl alcohol as the solvent. Isopropyl alcohol, classified as a class 3 solvent according to ICH Q3C guidelines, offers a safer and environmentally friendly alternative with minimal toxicity concerns. The method involves the measurement of absorbance at 274 nm the maximum wavelength (λmax) of ranolazine using a UV-visible spectrophotometer. Validation of the method, as per ich Q2(R1) guidelines, confirmed its accuracy,

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Krushi, Dadhaniya* Rajvi Dhimmar Reeya Patel Vruti Solanki Dr. Vikram Pandya. "Green Solvent Assisted UV–Spectrophotometric Method for Estimation of Efonadipine Hydrochloride Ethanolate in Bulk and Pharmaceutical Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 6 (2025): 1014–22. https://doi.org/10.5281/zenodo.15603154.

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A green solvent-assisted UV-spectrophotometric method has been developed and validated for the estimation of Efonidipine HCl Ethanolate in bulk and pharmaceutical dosage forms using Isopropyl alcohol as the solvent. Isopropyl alcohol, classified as a Class 3 solvent according to ICH Q3C guidelines, offers a safer and environmentally friendly alternative with minimal toxicity concerns. The method involves the measurement of absorbance at 251 nm the maximum wavelength (λmax) of Efonidipine HCl Ethanolate using a UV-visible spectrophotometer. Validation of the method, as per ICH Q2(R1) gui

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43

Subhadip C, Nalanda Baby R, Pridhvi Krishna G, Suraj M, and Shyamdeo Kumar T. "A New Second-Derivative Spectrophotometric Method for the Determination of Vildagliptin in Pharmaceutical dosage form." International Journal of Research in Pharmaceutical Sciences 12, no. 4 (2021): 2610–14. http://dx.doi.org/10.26452/ijrps.v12i4.4914.

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An accurate derivative spectrophotometric method was developed and validated for the determination of dipeptidyl peptidase inhibitor vildagliptin in the pharmaceutical dosage form. The second derivative of the UV spectra has enabled the estimation of vildagliptin absorbance at 217 nm without any interferences. Linearity, precision, accuracy, detection (LOD), and quantification (LOQ) limits were established for method validation. Calibration curve was linear in the range of 10-60 µg/mL with a regression coefficient of 0.998. The method was validated as per the International Conference on Harmon

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44

Choezom, Tenzin, and Bannimath Gurupadayya. "VALIDATED CHIRAL RP-UFLC METHOD FOR THE QUANTIFICATION OF CHLORTHALIDONE IN BULK AND PHARMACEUTICAL DOSAGE FORM." International Journal of Applied Pharmaceutics 9, no. 2 (2017): 22. http://dx.doi.org/10.22159/ijap.2017v9i2.16475.

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Objective: Development and validation of new, simple and reliable enantioselective reverse phase ultra-fast liquid chromatography (RP-UFLC) method for quantification of chlorthalidone in bulk and pharmaceutical dosage form.Methods: In the present study, the isocratic RP-UFLC method was developed on Phenomenex® Lux cellulose 4 column (250×4.6 mm, 5µ) and di-sodium hydrogen phosphate buffer (pH 3.6): methanol (40:60 v/v) as mobile phase. Elute was monitored at 240 nm with a flow rate of 1 ml/min.Results: The described method provided linear correlation (R2=0.999) between the range of 2-10 µg/ml.

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Jain, Hemant K., and Vishal K. Nikam. "DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION APIXABAN IN BULK AND TABLETS." International Journal of Applied Pharmaceutics 9, no. 5 (2017): 78. http://dx.doi.org/10.22159/ijap.2017v9i5.20028.

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Objective: To develop a simple and sensitive, high-performance thin layer chromatographic (HPTLC) method for the quantitative estimation of apixaban in bulk and tablets.Methods: Sample of apixaban was applied on silica gel 60 F254 TLC plates under pure nitrogen stream by linomat TLC applicator. Separation was carried out by using toluene, methanol and diethylamine as a mobile phase in a ratio of 16:3:1 v/v/v. Developed TLC plates were scanned by camag TLC scanner and detection was carried out at 288 nm.Results: Rf value of apixaban was found to be 0.4. The linearity was found from 50 to 350 ng

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46

Kumar, Manish, Ajay Kumar Shukla, Ram Singh Bishnoi, and C. P. Jain. "DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH." International Journal of Applied Pharmaceutics 10, no. 4 (2018): 92. http://dx.doi.org/10.22159/ijap.2018v10i4.26623.

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Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)” approach.Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using methanol as solvent and wavelength of 236 nm was selected as absorbance maxima (𝜆max). Effect of input variables on spectrum characteristics were studied for the selection of critical parameters and proposed method was validated for various parameters like system suitability, linearity, precision, acc

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Patel, Dhara, Jeel Dobariya, Prasanna Pradhan, Grishma Patel, and Dhananjay Meshram. "Development and Validation of UV Spectrophotometric methods for simultaneous estimation of Lobeglitazone Sulfate and Glimepiride in combined dosage form." Drug Analytical Research 8, no. 1 (2024): 62–69. http://dx.doi.org/10.22456/2527-2616.140749.

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Two UV spectrophotometric methods have been developed for accurately analyzing Lobeglitazone Sulfate and Glimepiride in combined dosage form, used in the treatment of type 2 diabetes mellitus. Method I, known as the simultaneous equation method (Vierodt’s Method), relies on measuring the absorption at 250 nm for Lobeglitazone Sulfate and 227 nm for Glimepiride, their respective λmax values. Method II involves the second-order derivative method, where the absorbance of Lobeglitazone Sulfate is measured at 297 nm (zero-crossing point of Glimepiride), and that of Glimepiride is measured at 259 nm

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Jongjitphisut, Nattapong, Worathat Thitikornpong, Wisut Wichitnithad, Thanundorn Thanusuwannasak, Opa Vajragupta, and Pornchai Rojsitthisak. "A Stability-Indicating Assay for Tetrahydrocurcumin-Diglutaric Acid and Its Applications to Evaluate Bioaccessibility in an In Vitro Digestive Model." Molecules 28, no. 4 (2023): 1678. http://dx.doi.org/10.3390/molecules28041678.

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A simple and reliable ultra-high-performance liquid chromatographic (UHPLC) method was developed and validated for determination of tetrahydrocurcumin diglutaric acid (TDG) and applied for evaluation of its bioaccessibility. The analytical method was validated to demonstrate as a stability-indicating assay (SIA) according to the ICH Q2(R1) guidelines under various force degradation conditions including thermal degradation, moisture, acid and base hydrolysis, oxidation, and photolysis. The developed chromatographic condition could completely separate all degradants from the analyte of interest.

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Jyothsna, Modugula 1. *. Dr. Manohar Babu. S. 2. Manohar reddy. J. 1. and Sushma R. 1. "A STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF CLOZAPINE BY UV SPECTROSCOPIC METHOD IN BULK AND TABLET DOSAGE FORM." Journal of Scientific Research in Pharmacy 8, no. 5 (2019): 48–53. https://doi.org/10.5281/zenodo.2677994.

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<strong><em>ABSTRACT</em></strong> <strong><em>Objective:</em></strong><em> To develop a stability indicating method development and validation of Clozapine by UV spectroscopic method in bulk and tablet dosage form and validate a simple, precise and cost-effective UV spectrophotometric method for the estimation of Clozapine according to the ICH Q2 (R1) guideline. </em> <strong><em>Methods:</em></strong><em> standard Clozapine solution was scanned over UV-Visible range for its wavelength of maximum absorbance. Various calibration standards of Clozapine were prepared and absorbance was recorded

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S, Sreenivasulu, Rameswara Rao M, and Chandra Sekhar KB. "A validated stability indicating RP-HPLC method for the quantification of Canagliflozin." International Journal of Research in Pharmaceutical Sciences 9, no. 1 (2018): 206. http://dx.doi.org/10.26452/ijrps.v9i1.1248.

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A simple, authentic and stability indicating high performance liquid chromatographic method for determination of Canagliflozin in bulk and pharmaceutical formulations was developed and validated as per ICH Q2 R1 Guidelines, A C18 Column (250mm length×4.6 mm diameter x 5 μm particle size) with a mobile phase consisting of Acetonitrile: 1-octanesulphonic acid in a ratio of 70:30 v/v was employed for the chromatographic study. A flow rate of 1.0 mL/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, P

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