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Щоб переглянути інші типи публікацій з цієї теми, перейдіть за посиланням: ICH Q2 (R1) Guidelines.

Статті в журналах з теми "ICH Q2 (R1) Guidelines"

Автор: Grafiati

Опубліковано: 3 червня 2025

Оновлено: 31 липня 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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Анотація:

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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2

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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3

Arun Kumawat, Jaymala, Vivek Kumar, Preeti, et al. "VALIDATION AND EVALUATION OF AN HPLC METHOD FOR QUANTIFICATION OF VITAMIN D3 IN PHARMACEUTICAL FORMULATIONS." Cuestiones de Fisioterapia 54, no. 4 (2025): 919–27. https://doi.org/10.48047/wy5sw824.

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Анотація:

In accordance with the guidelines provided by ICH Q2 (R1), the analytical procedure that you have described for quantifying vitamin D-3 through the use of HPLC is quite comprehensive and has been thoroughly validated. The apparatus appears to be reliable, as it consists of a C-18 column, a mobile phase consisting of methanol and water, and detection at 264 nm, which is an adequate wavelength for vitamin D-3 identification

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4

Padh, H., S. Parmar, and B. Patel. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM." International Journal of Applied Pharmaceutics 9, no. 6 (2017): 80. http://dx.doi.org/10.22159/ijap.2017v9i6.22214.

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Анотація:

Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.Results: The method showed a goo

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5

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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6

Gawande, V. T., and K. G. Bothara. "APPLICATION OF EXPERIMENTAL DESIGNS FOR OPTIMIZATION OF FORCED DEGRADATION STUDIES AND DEVELOPMENT OF STABILITY-INDICATING HPTLC METHOD FOR COMBINATION OF CEFPODOXIME PROXETIL AND OFLOXACIN." INDIAN DRUGS 55, no. 07 (2018): 49–58. http://dx.doi.org/10.53879/id.55.07.10851.

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A stability indicating HPTLC method was developed and validated for fixed dose combination of cefpodoxime proxetil and ofloxacin. TLC plates precoated with silica gel 60F254 were used as stationary phase and n propanol: ammonia (7:3 v/v) was used as mobile phase. Densitometric scanning was carried out at 290nm. Specificity of the method was established by peak purity studies. Method was validated as per ICH guidelines Q2 (R1) for accuracy, precision, linearity, sensitivity and robustness. Both the drugs were subjected to hydrolytic (acidic and basic), oxidative, thermal and photolytic stress a

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7

Venkata Kishore Ch, Tejeswara Rao V, Balaji K, Bala Prasad S, and Annapurna Nowduri. "Quantification of cefixime drug substances in pharmaceutical formulations by analytical GC." Open Access Research Journal of Chemistry and Pharmacy 2, no. 2 (2022): 001–11. http://dx.doi.org/10.53022/oarjcp.2022.2.2.0031.

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Анотація:

The present study was conducted to develop and validate an analytical procedure for the determination of cefixime in Pharmaceutical Formulations. The analytical test attributes and evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished products of cefixime and the method validation parameters were evaluated for the analytical test attribute cefixime meets the acceptance criteria. The results obtained were within the specified limits and the samples were analyzed for test item concentration by Gas Chromatography.

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8

Ankita, Thaikar* Deepti Bommanal Mayuri Shindhe Rashika Wagger Ujjanagouda Dannappanavar Veeranagoud Patil. "Extraction, Purification and Partial Estimation of Caffeine from Marketed Tea and Coffee Powder." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 3366–73. https://doi.org/10.5281/zenodo.14575565.

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The objective of present work is to extract, purify and partially estimate caffeinefrom marketed coffee and tea powder.UV-Spectrophotometric method was evolved using chloroform as solvent. The evolved method was standardized in terms of validation parameters such as simple, sensitive, linear as per ICH Q2 (R1). Guidelines for analysis of caffeine in marketed tea and coffee powder.Caffeine was extracted from different brands of marketed coffee and tea powder and was analyzed through different analytical methods like UV-Spectroscopy, Iodometric Titration, Solubility, Melting point, Thin Layer Ch

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9

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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Анотація:

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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10

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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11

Singh, R., and T. Khan. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES FOR THE ESTIMATION OF ASPIRIN, CLOPIDOGREL BISULPHATE AND ROSUVASTATIN CALCIUM IN FIXED DOSE COMBINATION (CAPSULE) BY UV SPECTROSCOPY." INDIAN DRUGS 54, no. 06 (2017): 43–47. http://dx.doi.org/10.53879/id.54.06.10885.

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Анотація:

A simple, accurate and precise UV spectroscopy method has been developed for the simultaneous estimation of aspirin, rosuvastatin calcium and clopidogrel bisulphate in fixed dose combination (capsule). The third order derivative spectra were used and 290.36 nm, 243.84 nm and 256.16 nm were selected as detection wavelengths. A linear calibration curve was obtained in the concentration range of 20-100 μg/mL for aspirin; 6-20 μg/mL for rosuvastatin calcium and 10-100 μg/mL for clopidogrel bisulphate. The developed method was validated as per the ICH guidelines Q2(R1) for linearity, range, accurac

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12

Jadhav, A. P. "ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR EVALUATION OF POLYHERBAL FORMULATION." INDIAN DRUGS 55, no. 10 (2018): 66–68. http://dx.doi.org/10.53879/id.55.10.10920.

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Talekt capsule is a branded polyherbal formulation used for enhancing the immune response to dermal infections and also for treating skin disorders. Curcumin and embelin, which are the active constituents of Haridra and Vidanga, respectively were used as marker compounds for developing a simple, accurate, precise and robust HPTLC method for simultaneous estimation. The mobile phase of toluene: ethyl acetate: formic acid (6.5: 3: 0.2 v/v/v) was used for separation. 381nm was used as wavelength for analysis. The Rf value obtained for curcumin, and embelin was found to be 0.51 ± 0.2 and 0.33 ± 0.

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13

Adhyapak, A. A., and A. P. Jadhav. "VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION AND QUANTIFICATION OF RESERPINE AND GALLIC ACID IN AN AYURVEDIC FORMULATION." INDIAN DRUGS 54, no. 09 (2017): 86–88. http://dx.doi.org/10.53879/id.54.09.11007.

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Анотація:

A simple, precise, accurate and robust RP-HPLC method was developed and validated for simultaneous estimation of reserpine and gallic acid in an ayurvedic formulation. The two markers were resolved using a C-18 column make Hemochrom Instil using the mobile phase acetonitrile: water (pH 5.6 adjusted using orthophosphoric acid) in the ratio 75:25 V/V at a flow rate of 0.8 mL/min. Retention times of reserpine and gallic acid were 8.178 ± 0.2 minutes and 2.527 ± 0.2 minutes respectively, at 229 nm. The developed method was validated on the basis of ICH Q2 (R1) guidelines. The developed method was

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14

Sankar, K., and A. P. Jadhav. "RP-HPLC METHOD DEVELOPMENT AND ITS VALIDATION FOR EVALUATION OF POLYHERBAL FORMULATION." INDIAN DRUGS 54, no. 10 (2017): 68–70. http://dx.doi.org/10.53879/id.54.10.11008.

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Анотація:

Curcumin and embelin, which are the active constituents of Haridra and Vidanga, respectively, were used as marker compounds for developing a simple, accurate, precise and robust RP-HPLC method for simultaneous estimation from Talekt capsule. It is a polyherbal formulation used for enhancing the immune response to dermal infections and also for treating skin disorders. The mobile phase of methanol: 1% ortho phosphoric acid in water in the ratio of 90:10 V/V was used for separation. Retention time of curcumin and embelin were found to be 2.77 ± 0.2 minutes and 7.77 ± 0.2 minutes, respectively. T

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15

M., Maste Meenaxi, Gawas Nikhil S., Utkarsh Shashtri, and Poonam Shelar. "RP-HPLC Method Development and Validation for Pioglitazone in Bulk and Marketed Formulation." Der Pharma Chemica 13, no. 6 (2021): 10. https://doi.org/10.5281/zenodo.11072414.

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Анотація:

The work describes a precise, accurate and reproducible Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for development and validation of Pioglitazone in tablet dosage form on Lachrome Liquid chromatographic system having PDA-20 A UV/VIS Detector using stationary phase C18 column (300 mm × 3.9 mm, 5 µm, particle size) and acetonitrile:phosphate buffer, (50:50 v/v) as mobile phase at flow rate of 1.00 ml/min and the detection wavelength was 267 nm. The retention time for Pioglitazone was found to be 8.08 min. The method was validated for precision, accuracy, l

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16

Nandini, Sivapuram, and Dr U. Mohan Kumar. "A new validated RP-HPLC method developed and validated for the simultaneous estimation of lobiglitazone and glimperide in bulk drug and pharmaceutical dosage form." International Journal of Experimental and Biomedical Research 4, no. 2 (2025): 25–37. https://doi.org/10.26452/ijebr.v4i2.776.

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Анотація:

The current work aims to create a new, simple, rapid, quick, accurate, efficient, and reproducible RP-HPLC method for the simultaneous analysis of Lobiglitazone and Glimperide. In compliance with ICH criteria, the developed approach will undergo validation. Through chromatographic condition optimisation, the RP-HPLC method will be used to establish the analytical method for the simultaneous quantification of Glimperide and Lobiglitazone. For a number of factors included in ICH standards, Q2, the developed approach has been validated in accordance with ICH guidelines (R1). According to a survey

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17

Baghel, Madhuri, Sangeeta Patil, Mukesh Sharma, et al. "Degradation Kinetic Study and Mechanistic Interpretation of Hydrolysis of Pidotimod by LC-MS/MS: A QbD Assisted Stability Indicating Method Development." Asian Journal of Chemistry 34, no. 11 (2022): 2797–805. http://dx.doi.org/10.14233/ajchem.2022.23796.

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Анотація:

The stability of pidotimod was investigated in this study under ICH-recommended stress degradation conditions. To explore the degradation kinetics of pidotimod, a QbD assisted stability indicating assay method was designed and validated according to ICH Q2 (R1) guidelines. The impacts of hydrogen and hydroxide ions were explored, with a focus on the kinetics of pidotimod hydrolytic degradation to identify the rate laws, which were parameterized using linear regression analysis. The degradation product (DP2) was formed as a major degradation product of hydrolysis. Four known and one unknown deg

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18

Prajapati, Krunal J., and Charmy Kothari. "Development and Validation of a Stability Indicating LC-MS/MS Method for the Determination of Clenbuterol HCl." Drug Research 70, no. 12 (2020): 552–62. http://dx.doi.org/10.1055/a-1167-0529.

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Анотація:

AbstractClenbuterol hydrochloride (CLT), β2 adrenergic agonist is used as a bronchodilator in the therapeutic treatment of asthma. It is important to know the stability behaviour of the drug in different degradation conditions as per ICH Q1A (R2) guidelines for safety and efficacy purpose. The main objective of the study is to develop and validate stability indicating LC-MS/MS method for the determination of Clenbuterol HCl. The separation was achieved using Phenomenex Gemini NX C18 (250*4.6 mm, 5 μ) column and the mobile phase consisting of ammonium acetate buffer (5 mM), 0.15% triethylamine

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19

Jahan, Sadia, Md Mahbubul Alam, Md Samiul Islam, Dilshad Noor Lira, and Abu Shara Shamsur Rouf. "Stress Degradation Studies and Development of a Validated RP-UHPLC Method of Ledipasvir." Malaysian Journal of Pharmaceutical Sciences 20, no. 1 (2022): 25–37. http://dx.doi.org/10.21315/mjps2022.20.1.3.

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Анотація:

The intent of the research work was to develop and validate a simple, selective and precise reversed phase ultra-high performance liquid chromatography (RP-UHPLC) method for the determination of ledipasvir. A forced degradation study was performed as per International Conference on Harmonisation (ICH) guidelines Q1A (R2) and Q1B. Ledipasvir was found to be well separated from degradation products using an analytical C18 column (150 mm × 4.6 mm i.d., 5 μm particle size) with a ratio of mobile phase (75:25 v/v) consisting of methanol and 0.1% trifluoroacetic acid (TFA) kept at ambient temperatur

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20

Patel, Satish A., and Dharmendrasinh A. Baria. "DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF NAPHAZOLINE HCL AND PHENYLEPHRINE HCL IN EYE DROPS." INDIAN DRUGS 57, no. 06 (2020): 26–31. http://dx.doi.org/10.53879/id.57.06.11613.

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Анотація:

A first order derivative UV-spectrophotometric method was developed to quantify naphazoline hydrochloride and phenylephrine hydrochloride in eye drops. Naphazoline hydrochloride and phenylephrine hydrochloride were estimated at 275.6nm (zero crossover point of phenylephrine hydrochloride) and 289.4nm (zero crossover point of naphazoline hydrochloride), respectively. The method was found to be linear in the concentration range of 10 - 25 µg/ml for naphazoline hydrochloride and 20 - 60 µg/ml for phenylephrine hydrochloride. The developed method was subjected to validation in accordance with ICH

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21

Ghule, A. S., T. Thomas, M. Joseph, K. S. Navya Sree, and K. Bhat. "SIMULTANEOUS ESTIMATION OF TELMISARTAN, HYDROCHLOROTHIAZIDE AND AMLODIPINE BESYLATE IN TABLET PREPARATION BY CHEMOMETRIC ASSISTED SPECTROPHOTOMETRIC ANALYSIS." INDIAN DRUGS 55, no. 07 (2018): 59–66. http://dx.doi.org/10.53879/id.55.07.11109.

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A chemometric method was developed by application of Partial Least Square regression to for the simultaneous estimation of telmisartan, hydrochlorothiazide and amlodipine besylate in tablet preparations. Calibration set was prepared considering seven sets; each set with twenty-four mixed solutions and twenty-one ternary mixed solutions, were prepared as a validation set. The absorbance data matrix for training set was obtained by recording absorbance within wavelength range 220-320 nm at 2nm intervals. The developed method was validated according to ICH Q2 (R1) guidelines and results were repo

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22

M., Kashid Arun, Mhatre Dhanshree S., Tathe Shraddha V., Mahajan Moreshwar P., and Polshettiwar Pranali P. "RP-HPLC Method Development and Validation for Emtricitabine and Tenofovir Alafenamide fumarate in bulk drug and its degraded products using Design of Experiments." Der Pharma Chemica 14, no. 7 (2022): 20. https://doi.org/10.4172/0975-413X.14.7.29-48.

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Анотація:

RP-HPLC method development was successfully done using an innovative methodology based on the design of experiments (DoE), independent component analysis (ICA), and design space (DS). The Quantification of an HIV drug combination of Emtricitabine and Tenofovir alafenamide fumarate was done using DoE. Initially, independent variables that affect the dependent variables were analyzed and the Box Behnken design was used to study the interaction between the independent variables and dependent variables. The variables selected were % of the aqueous phase, flow rate, and wavelength. These variables

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23

N, Srinidhi Goud. "Development and Validation of RP-HPLC Method for the Quantitative Estimation of Favipiravir in Bulk and Pharmaceutical Dosage Form." YMER Digital 21, no. 06 (2022): 1066–85. http://dx.doi.org/10.37896/ymer21.06/a3.

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Favipiravir is an antiviral drug, used in the treatment of SARS-COV-2, novel corona virus. It is a pyrazine carboxamide derivative with activity against RNA viruses A sensitive new RP-HPLC method was developed for the quantitative estimation of Favipiravir in bulk and pharmaceutical dosage form using Rivaroxaban as internal standard (IS). The separation of drug was achieved by Enable C18 column using acetonitrile and water as mobile phase at a ratio of 70:30 %v/v with a flow rate of 1mL/min and wavelength at 296nm respectively. The retention time of Favipiravir and Rivaroxaban were found to be

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24

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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25

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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Анотація:

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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26

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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Анотація:

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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27

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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Анотація:

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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28

A. Patel, Satish, and Dharmendrasinh A. Baria. "SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS DETERMINATION OF SULPHACETAMIDE SODIUM AND PREDNISOLONE ACETATE IN OPHTHALMIC FORMULATION." Indian Drugs 60, no. 02 (2023): 83–85. http://dx.doi.org/10.53879/id.60.02.12594.

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Анотація:

A simple, precise, accurate, and rapid derivative spectrophotometric approach for the simultaneous quantification of sulfacetamide sodium (SUL) and prednisolone acetate (PRE) in the combined dosage form has been established and validated. The wavelengths selected for analysis are 230 nm (ZCP of SUL) and 244 nm (ZCP of PRE) for SUL and PRE, respectively. The suggested technique has exhibited linearity for a concentration range of 2–6 µg mL-1 for PRE and 5–15 µg mL-1 for SUL, respectively. Both medications had percentage recoveries that varied from 99.41 to 101.8. The suggested approach has been

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Rani, J. David Blessing, and C. Asha Deepti. "Liquid Chromatographic-Electron Spray Ionization-Mass Spectroscopy Technique for the Simultaneous Determination of Ethinyl Estradiol & Etonogestrel and Characterization of New Forced Degradation Compounds." Asian Journal of Chemistry 35, no. 12 (2023): 3105–10. http://dx.doi.org/10.14233/ajchem.2023.30700.

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Анотація:

The aim of the current study was to develop, validate a precise, rapid, accurate liquid chromatography-mass spectrometry (LC-MS) method for the simultaneous estimation of ethinyl estradiol and etonogestrel. The retention times of ethinyl estradiol and etonogestrel were found at 3.112 min and 4.399 min, respectively, whereas the linear range were found in the concentration ranges from 0.04-0.23 µg/mL & 3-18 µg/mL with slope coefficient (R2) of 0.9992 and 0.9991 correspondingly. Similarly, the accuracy values for ethinyl estradiol and etonogestrel were found to be 100.5% and 100.1% correspon

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30

Viju, Christina, Sneha A. Agrawal, and Aruna P. Jadhav. "DEVELOPMENT AND VALIDATION OF A NOVEL HPTLC METHOD FOR QUANTITATIVE ESTIMATION OF VINCAMINE FROM CATHARANTHUS ROSEUS LINN. LEAVES EXTRACT." INDIAN DRUGS 60, no. 10 (2023): 48–52. http://dx.doi.org/10.53879/id.60.10.14128.

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Анотація:

Catharanthus roseus (Apocynaceae), commonly known as periwinkle, is a perennial plant that is mostly found in Southern Asia. Periwinkle is rich in indole alkaloids. This research work consists of the development and validation of one of the indole alkaloids, vincamine, by HPTLC. The chromatographic separation was achieved by using eluent chloroform, acetone, and formic acid in the ratio of 5:1:0.5 V/V/V at wavelength 222 nm. With an Rf value of 0.33±0.02, this method showed good separation of vincamine in the extract. Vincamine in the range of 200-1000 ng spot-1 showed a satisfactory linear re

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31

Mohanbhai, Prajapati Laxmanbhai, Malek Sohanabanu Mustaqhusen, Joshi Amit Kamleshbhai, and Kharodiya Mohammadali Liyakatali. "SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION." Tropical Journal of Pharmaceutical and Life Sciences 5, no. 1 (2018): 01–07. https://doi.org/10.61280/tjpls.v5i1.7.

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Анотація:

The present study was aimed to develop a novel simple, accurate, precise, robust and economic UV-spectrophotometric method for estimation of benidipine hydrochloride in pharmaceutical formulation. The developed method was validated with accordance to ICH Q2 (R1) guidelines. Beer’s law was obeyed in the concentration range 1-3.5µg/mL with correlation coefficient of 0.9938. The sensitivity was checked as the limit of detection and limit of quantitation which were found to be 0.04540 and 0.1375µg/mL respectively. A further study of the accuracy of the proposed method was performed using standard

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32

Shareef, Isteyaq, and Kumaraswamy Gandla. "Stability-Indicating UPLC Method Development and Validation for Sulfamethoxazole and Trimethoprim Injection with Comprehensive Forced Degradation Profiling." Journal of Drug Delivery and Therapeutics 15, no. 6 (2025): 132–36. https://doi.org/10.22270/jddt.v15i6.7224.

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Анотація:

Objective: To develop and validate a stability-indicating UPLC method for the simultaneous estimation of Sulfamethoxazole and Trimethoprim in injectable dosage form, including comprehensive forced degradation profiling as per ICH guidelines. Design: Experimental study involving method development, validation, and forced degradation in accordance with ICH Q2(R1) and Q1A(R2) protocols. Intervention: Chromatographic separation was achieved using a C18 column (150×4.6 mm, 5 µm) with a mobile phase of Methanol:Acetonitrile (80:20 v/v), a flow rate of 1.0 mL/min, and UV detection at 254 nm. Main Out

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33

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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Анотація:

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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34

Gandhi, S. P., M. G. Dewani, T. C. Borole, and M. C. Damle. "Development and Validation of Stability Indicating HPTLC Method for Determination of Diacerein and Aceclofenac as Bulk Drug and in Tablet Dosage Form." E-Journal of Chemistry 9, no. 4 (2012): 2023–28. http://dx.doi.org/10.1155/2012/719264.

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Анотація:

Diacerein is a drug for osteoarthritis and is di-acetylated derivative of rein. Aceclofenac is used as an effective non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. The present study describes degradation of diacerein and aceclofenac under ICH prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat, and photolysis) and establishment of a stability-indicating HPTLC assay method. Different degradation peaks were observed for diacerein when it was exposed to alkaline, and acid catalysed hydrolysis. For aceclofenac, decreas

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35

Song, Eunchae, Chanhong Min, Eunjae Kim, et al. "Development and Validation of a Solvent-Free Headspace GC-MS Method for the Screening of Benzyl Chloride in Pharmaceutical Products." Chemosensors 11, no. 9 (2023): 487. http://dx.doi.org/10.3390/chemosensors11090487.

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Анотація:

This study presents a solvent-free headspace gas chromatography–mass spectrometry (SF-HS-GC/MS) method for robustly screening benzyl chloride, a mutagenic carcinogen, impurities in active pharmaceutical ingredients (APIs) and drug products. The SF-HS-GC/MS method simplifies analysis by eliminating solvent use, reducing matrix interference. Optimized headspace parameters include incubation temperature, time, and sample amount. Validation, aligned with Q2(R1) ICH guidelines and ICH M7 recommendations, covers selectivity, linearity, limit of detection (LOD), limit of quantification (LOQ), precisi

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Dr.A.M.Tamboli, Dr A. M. Tamboli, Swapnil Bajirao Hole Swapnil Bajirao Hole, Mahesh Chakradhar Gore Mahesh Chakradhar Gore, and Vinay Shivaji Kamble Vinay Shivaji Kamble. "Development and Validation of RP-HPLC Analytical Method for Simultaneous Estimation of Dapagliflozin and Vildagliptin in Pure and It’s Pharmaceutical Dosage Forms." International Journal of Pharmaceutical Research and Applications 10, no. 3 (2025): 1468–80. https://doi.org/10.35629/4494-100314681480.

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Анотація:

The present study aimed to develop and validate a reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of dapagliflozin and vildagliptin in a tablet dosage form that was simple, sensitive, accurate, and reproducible.The chromatographic measurement was performed on a Phenomenex C8 column (150x4.6 mm, 5 um) column with an optimized mobile phase containing 0.1% Perchloric acid: ACN in ratio of 55:45.The flow rate was 0.5 ml/min,and the detecting wavelength was 214n nm.. In the concentration range Dapagliflozin and Vildagliptin were of 8 to 12μg

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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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Анотація:

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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38

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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Анотація:

<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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39

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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Анотація:

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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40

Gawande, Vandana, and Varsha Jadhav. "Validated stability indicating assay method for tenofovir implementing design of experiment approach for forced degradation." International Journal of Bio-Pharma Research 8, no. 1 (2019): 2468–75. http://dx.doi.org/10.21746/ijbpr.2019.8.1.1.

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Анотація:

Tenofovir, an antiretroviral drug known as nucleoside analogue reverse transcriptase inhibitor, was evaluated for its degradation behavior. The study involved optimization of forced degradation study using the design of experiment (DoE) approach and validation of developed stability indicating assay method (SIAM) for tenofovir. Chromatographic separation was achieved on Kromasil C18 column using mixture of methanol and ammonium acetate buffer pH 8.5 as mobile phase in isocratic elution mode. Detection was done using PDA detector. Tenofovir showed degradation at alkali, acid hydrolysis and oxid

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41

Wagh, Mayur, and Tabassum Khan. "ESTIMATION OF RESVERATROL AND GLABRIDIN IN GEL FORMULATION BY UV SPECTROSCOPY." INDIAN DRUGS 61, no. 08 (2024): 70–73. http://dx.doi.org/10.53879/id.61.08.14660.

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Анотація:

Acne and hyperpigmentation are the most common problems in adolescents globally. Resveratrol and glabridin are proven to be effective against acne and hyperpigmentation. We developed a gel comprising these two actives for acne and hyperpigmentation treatment. The purpose was to establish a reliable UV method of analysis for quantification of resveratrol and glabridin, with high precision and accuracy. UV spectral analysis indicated 306nm and 281nm to be the λmax for resveratrol and glabridin, respectively, in methanol. The linearity studies conducted as per ICH guidelines Q2 R1 resulted in a c

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42

Saradhi, NDVR, N. Madan Gopal, C. Madhusudhna Chetty, and K. Sushmitha. "Isolation, Characterization & Phytochemical Screening, Analytical Method Development and Validation for the Determination of Catechins in B.ciliata by RP HPLC Method." International Journal of PharmTech Research 13, no. 2 (2020): 18–24. http://dx.doi.org/10.20902/ijptr.2019.130203.

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Анотація:

Ayurveda, an ancient system of medicines detailing a number of medicinal plants and their activities in human or animals. The present research work was aimed to develop an analytical procedure for the determination of catechins in the selected plant - B.Ciliata. It is famously known as stone flower/ stone breaker having various biological activities like anti urolithiatic, antiviral, antidiabetic antitumor and cardio protective activity. The methanolic extract of the plant is isolated and a method is developed by using RP HPLC for the determination of catechins in the crude plant extract using

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43

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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Анотація:

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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44

Bhusari, Vidhya K., Utkarsh S. Bhosale, Nikita K. Jagtap, and Minal R. Ghante. "FORCED DEGRADATION STUDIES FOR ETHAMBUTOL BY RP-HPLC." INDIAN DRUGS 60, no. 08 (2023): 80–86. http://dx.doi.org/10.53879/id.60.08.13714.

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Анотація:

Literature survey of ethambutol reveals no stability indicating analytical method being reported for estimation, either in bulk or in a pharmaceutical dosage form. Therefore, a stability indicating analytical method needed to be developed and validated. In the current research, a RP-HPLC method was developed to separate ethambutol from its degradation products. Ethambutol is exposed to stressors like hydrolysis, oxidation, neutral (water), and photolysis decomposition, and the degradation products were separated using an ODS Hypersil C-18 column. Buffer: acetonitrile was used as mobile phase a

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45

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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Анотація:

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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46

Deshmukh, P. P. M., P. T. Giri, A. B. Ghogare, et al. "METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IPRATROPIUM BROMIDE AND MOMETASONE FUROATE USING RP-HPLC." Rasayan J. Chem 17, no. 02 (2024): 343–55. http://dx.doi.org/10.31788/rjc.2024.1728757.

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Анотація:

The present work aimed to develop a suitable, specific, simple, precise, robust, and reproducible analytical method using RP-HPLC for simultaneous estimation of Ipratropium bromide and Mometasone furoate. The separation was carried out using mobile phase Acetonitrile: Phosphate buffer (pH modified up to 3.7 by orthophosphoric acid) in the ratio of 50:50 % v/v at 1 ml/min flow rate and detection was carried out at 210 nm. The method was validated by determining system specificity, selectivity, suitability, linearity, precision, accuracy, robustness, and LOQ-LOD as per ICH Q2 (R1) guidelines. Th

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Punam, N. Bandgar Monika G. Shinde Pradnya P.Shinde Aishwarya A. Ubale. "Simultaneous Estimation Of Bilastine And Montelukast In Bulk And Pharmaceutical Dosage Form By UV Spectroscopy." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 799–808. https://doi.org/10.5281/zenodo.12736786.

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Анотація:

The ultraviolet (UV) method was developed for the purpose of determining the amount of bilastine and montelukast present in bulk and pharmaceutical dosage form. An ultraviolet-visible spectrophotometer was utilized in order to carry out the identification and quantification processes. The mixture of 0.1% perchloric acid and acetonitrile was employed as a diluent for the preparation of samples and standards, as well as a blank. Researchers discovered that the wavelength of the medicine Montelukast was 254 nm, while the wavelength of the drug Bilastine was 270 nm  An effort has been made to

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Dr, Kumar Raja Jayavarapu* M. Manikanta M. Dharani M. Mani Likitha. "UV Spectroscopic Estimation of Brivaracetam in Bulk Drug and Formulations." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 2224–29. https://doi.org/10.5281/zenodo.15085737.

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Анотація:

Epilepsy is characterized by recurring, uncontrollable seizures and associated co-morbidities. Convulsion episodes are caused by aberrant brain activity that manifests as symptoms and indicators for a short time. A novel, uncomplicated, accurate, basic, exact, and reasonably priced ultraviolet (UV) spectrophotometric approach with an enhanced detection range was created for the current investigation. Following a review of the literature, we discovered that there was only one way for estimating brivaracetam, which motivated us to create further techniques utilizing a UV spectrophotometer. Briva

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Fernandes, Adison, and P. N. Sanjay Pai. "Development and Validation of Stability Indicating RP-HPLC Assay Method for Mefenamic Acid." Asian Journal of Chemistry 31, no. 3 (2019): 656–60. http://dx.doi.org/10.14233/ajchem.2019.21754.

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Анотація:

The present research work was carried out to evaluate the stability behaviour of mefenamic acid under ICH Q1A (R2) recommended stress conditions. The drug was subjected to hydrolytic, oxidative, photolytic and thermal stress conditions. The drug was found susceptible to degradation under oxidative stress condition but was stable under hydrolytic, photolytic and thermal stress conditions. A total two degradation products were formed, which were separated using HPLC. The chromatographic separation was carried out on Sunfire ODS C-18 (250 × 4.6 mm, 5 μm) column. Optimum resolution was obtained us

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Shelke, Sayli, Bhagyashri Patil, Vikesh Kukade, and Chandrakantkewari Chandrakantkewari. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR AMLODIPINE BESYLATE AND LISINOPRIL IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD." Journal of Advanced Scientific Research 14, no. 07 (2023): 63–68. http://dx.doi.org/10.55218/jasr.202314710.

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Анотація:

   The purpose of this study was to develop and validate a simple, sensitive, accurate, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amlodipine besylate and lisinopril in a Tablet dosage form. The chromatographic measurement was performed on a Phenomenex C18 (250 × 4.6 mm, 5um) column with an optimised Acetate buffer mobile phase: Methanol (65:35). The flow rate was one ml/min, and the detecting wavelength was 221 nm. Triethanolamine was used to adjust the pH to 5. In the concentration range of 4-20 ug/m

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