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Journal articles on the topic 'Validation as per ICH guidelines'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Bhatia, Ritika, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol tablet as per ICH guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 11–23. http://dx.doi.org/10.32553/ijmbs.v7i6.2713.

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Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emp

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Tayyaba, Mahtab*and S. Ramya Sri. "RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALPRAZOLAM AND IMIPRAMINE AS PER ICH GUIDELINES." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2027–39. https://doi.org/10.5281/zenodo.1214513.

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A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Alprazolam and Imipramine, in its pure form as well as in tablet dosage form. Chromatography was carried out on an Inertsil column, C18(150x4.6 ID) 5µm column using a mixture of Phosphate buffer : ACN (30:70) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 238nm. The Retention Time of the 2.397min for Alprazolam and 3.493 min for Imipramine. The method produce linear responses in the concentration range of 0.5-1.5µg /ml for Alpra

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Shantappa Birajdar, Arunadevi. "New Method Development by HPLC and Validation as per ICH Guidelines." Acta Scientific Pharmaceutical Sciences 4, no. 4 (2020): 55–60. http://dx.doi.org/10.31080/asps.2020.04.0517.

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4

Shah, Devanshi, Vinit Movaliya, Shruti Kharidia, and Maitreyi Zaveri. "Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines." International Journal of Drug Regulatory Affairs 12, no. 2 (2024): 58–64. http://dx.doi.org/10.22270/ijdra.v12i2.675.

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Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory

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Vikas, Chougule, Rajmane Manjiri, Chougule Nilesh, Desai Abhishek, Rohile Vinayak, and Inamdar Nasruddin. "Development Of Reverse-Phase High-Performance Liquid Chromatographic and UV-Spectrophotometric Method with Validation For Octenidine Dihydrochloride." American Journal of PharmTech Research 12, no. 3 (2022): 179–88. https://doi.org/10.5281/zenodo.7106700.

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ABSTRACT The purpose of this research is to develop and validate a precise method for UV-Vis spectrophotometric and Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) for determination of Octenidine dihydrochloride in bulk and pharmaceutical preparation. According to the relevant experiment the maximum wavelength was found to be 285nm and it is used for further process of development of method and its validation. The developed methods used for quantitative estimation of Octenidine dihydrochloride in pharmaceutical preparation and bulk drug which shows the satisfactory results as pe

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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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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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Prajapati, J. B., H. Rao, and H. Shah. "DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SELEGILINE HYDROCHLORIDE LOADED SOLID LIPID NANOPARTICLES." INDIAN DRUGS 56, no. 08 (2019): 57–60. http://dx.doi.org/10.53879/id.56.08.11297.

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The present paper discusses about a simple, precise and validated method for the determination of selegiline loaded solid lipid nanoparticles. The study was carried as per the parameters laid down in ICH guidelines. Maximum wavelength of selegiline in 8:2 methanol: chloroform mixture was selected at 258nm. The method was found to be linear in the range of 200μg/mL to 1000μg/mL with correlation coefficient R2 of 0.994. Method was successfully validating as per ICH guidelines. Moreover, this method was simple, sensitive and easy to apply and can be performed at laboratory scale. Hence, the propo

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8

Sahu, Sandeep, and Narendra Kumar Lariya. "Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 1236–39. http://dx.doi.org/10.22270/jddt.v9i4-s.3972.

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Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.28

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9

Dr., A. Madhukar *. Gariganti Swathi 1. Tanveer Fatima 2. Amina Fatima 2. Madhia Nikhat 2. Mohd Akram Mohsin 2. "A Simple Method Development and Validation for the Determination of Tolbutamide in Bulk and Marketed Dosage Form by UV - Spectrophotometric Technique." Journal of Pharma Research 9, no. 7 (2020): 6. https://doi.org/10.5281/zenodo.3931525.

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ABSTRACT The present work was to develop simple UV spectrophotometric methods for estimation of Tolbutamide (TOL) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Tolbutamide. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.49% and 100.78% respectively. The methods were validat

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Borkar, Dinesh P., Anup Barsagade, Nobel CP James, Suruchi Thakare, and Susmita Mandal. "Analytical Method Developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP-HPLC in Combination Dosage Form." Journal of Pharmaceutical Research International 36, no. 11 (2024): 163–73. http://dx.doi.org/10.9734/jpri/2024/v36i117609.

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A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of drugs in a combined pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in combination dosage form. The aim is "Analytical Method developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP- HPLC In C

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V.Shirisha*, K.Sarika Reddy SK.Akbar J.Vamshi K.Archana Santhosh Illendula K.N.V.Rao K. Rajeswar Dutt. "METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV-SPECTROSCOPIC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 8017–23. https://doi.org/10.5281/zenodo.2647584.

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<em>A simple, sensitive, highly accurate spectrophotometric method has been developed for the determination of Dapagliflozin in bulk and pharmaceutical tablet dosage form as per ICH Guidelines. The adequate drug solubility and maximum assay sensitivity was found in sodium citrate. The absorbance of Dapagliflozin was measured at 231 nm in the wavelength range of 200‐400 nm. Beer’s law was obeyed in the concentration range of 10-50 μg/mL, in the linearity study regression equation was found to be y =0.2125x+0.0085 & amp; correlation coefficient was found to be 0.999. This method was

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Shashi, Daksh, and Goyal Anju. "Analytical Method Development and Validation: A Review." Chemistry Research Journal 5, no. 3 (2020): 173–86. https://doi.org/10.5281/zenodo.12589409.

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<strong>Abstract </strong>This review focuses on approach to the validation of HPLC method with the compliance of restrictive needs and accepted pharmaceutical practices. The information during this review provides the explanations for performing analytical method validation. The validation parameters needed to be performed in validation for assay and organic impurities strategies. Individual validation parameters are mentioned in reference to the kind of method such assay and organic impurities method to be valid. This review was written to assist chemists/analysts to perform for method valid

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Kartik, A. Bhatkar*1 V. M. Waghulkar2 M. P. Jadhao3 M. D. Game4 S. G. Jawarkar5. "Analytical Method Development And Validation For Simultaneous Estimation Of Antidibetic Drugs In Bulk And Marketed Formulation." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 524–31. https://doi.org/10.5281/zenodo.11183408.

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A new, simple, selective, accurate, rapid and precise   High-Performance Liquid Chromatographic technique of Dapagliflozin and Linagliptin was established as per ICH Guidelines. HPLC was performed on a Hypersil BDS Column C18, 5 µm particle size, 245 cm × 4.6 mm with phosphate buffer and acetonitrile, Methanol in the ratio of 15: 15: 70 v/v as a mobile phase and a flow rate of 1.0 ml min-1. UV detection was performed at 284 nm.  The retention time of Dapagliflozin was found to be 3.961 minutes, and Linagliptin was found to be 3.451.  Validation of the developed

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Chawale, Prajakta A., Dinesh R. Chaple, Alpana J. Asnani, and Kumar Pratyush. "Development and Validation of UV Spectrophotometric Method for Estimation Ibandronate sodium in Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 9, no. 3 (2019): 339–43. http://dx.doi.org/10.22270/jddt.v9i3.2675.

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A simple, accurate, precise, rapid spectrophotometric method for estimation of Ibandronate sodium in pharmaceutical formulation. Ibandronate sodium is one off the nitrogen carrying bisphosphonate. It prevents osteoclast-conciliate bone resorption, Paget’s disease, postmenopausal osteoporosis. The maximum wavelength (λmax) of ibandronate sodium is 218nm. Linearity was observed in the concentration range 2-100µg/ml. The coefficient of variation value was found to be 0.3499. Amount of drug estimated from tablet formulation were in precise with label claim. The method was statistically validated a

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Mohammad, Afrin Roshanara* Mekala Indu Bhavani A. Elphine Prabahar and Rama Rao Nadendla. "DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ANALYSIS OF ENALAPRIL MALEATE IN BULK AND PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 02 (2019): 4049–53. https://doi.org/10.5281/zenodo.2567493.

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<em>A simple, accurate, sensitive, precise and economical spectroscopic method has been developed and validated for the determination of enalapril maleate in bulk and tablet dosage form. The solvent used is double distilled water for solubilizing purpose. The drug shows the absorption maxima of 211nm. The method obeys Beer’s law in the concentration range of 10-60  μg/mL and exhibited good correlation coefficient (R2=0.9983). The developed method is validated statistically as per ICH guidelines for linearity, precision and accuracy.</em> <strong>Keywords: </strong><em>Enalapril m

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Poonam, D. Dighe, S. Wakale Vijay, .G.Y Dama, et al. "Assay Method Development and Validation for Simultaneous Estimation of Mometasone Furoate and Azelastine HCL for Nasal Spray by RP-HPLC." Journal of Pharmaceutical Quality Assurance and Quality Control 1, no. 2 (2019): 1–22. https://doi.org/10.5281/zenodo.3040688.

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<em>A simple, precise, accurate, method was developed and validated for analysis of Mometasone Furoate and Azelastine Hydrochloride in nasal spray formulations. For development, different chromatographic condition and stress conditions like acid, base, peroxide, thermal and humidity as per ICH guidelines were used. Method was developed on reversed-phase C<sub>18</sub> column using a mobile phase consisting of potassium dihydrogen, phosphate buffer and acetonitrile. Other HPLC parameters were flow rare 1 ml/min, detection wavelength 239 nm, injection volume 20 </em><em>µl</em><em> and col

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Arla, Rambabu, Srinivasa Rao J, and Kailasam Koumaravelou. "Quantitative determination and validation of ethylhexylglycerin using Gas chromatography method." International Journal of Research in Pharmaceutical Sciences 9, no. 1 (2018): 30. http://dx.doi.org/10.26452/ijrps.v9i1.1154.

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Ethylhexylglycerin, an alkyl glyceryl ether, used in various cosmetics and deodorants is also known to have anti-microbial activity and hence used as an adjuvant along with other preservatives to produce synergistic effect. In the present study, a gas chromatographic method has been employed and validated to determine the presence of impurities along with ethylhexylglycerin. A column having the dimension of DB-1 30m x 0.32mm; 0.25µm with acetone as solvent was found to be optimal for the ideal separation of ethylhexylglycerin from its impurities. Injection volume was set to 1 µl and temperatur

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Singh, Anamika, and Tamanna Narsinghan. "BIOANALYTICAL METHOD VALIDATION: A COMPREHENSIVE ASSESSMENT OF VARIOUS REGULATORY GUIDELINES." Indian Drugs 60, no. 06 (2023): 7–25. http://dx.doi.org/10.53879/id.60.06.12583.

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Bioanalytical methods are used to analyse an analyte in a biological matrix. Bioanalytical method validation is the process of determining the suitability of the given bioanalytical methodology for providing the required analytical data. Validation of the bioanalytical methods demonstrates and ensures that the methods used for the quantification of analyte in biological fluids are reliable, reproducible and suitable for its intended application. Different regulatory agencies like Food and Drug administration (FDA), The National Health Surveillance Agency or Agência Nacional de Vigilância Sanit

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V V, Wamorkar, C. S. Ramaa, Manjunath S Y, and V. Malla Reddy. "Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug." International Journal of Pharmaceutical Sciences and Nanotechnology 3, no. 2 (2010): 978–86. http://dx.doi.org/10.37285/ijpsn.2010.3.2.11.

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RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the str

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Kulkarni, Dipak Chandrakant, Anima Sunil Dadhich, and Mukthinuthalapati Mathrusri Annapurna. "Analytical method development and validation for the evaluation of related substances in Apalutamide by RP-HPLC." Journal of Drug Delivery and Therapeutics 14, no. 6 (2024): 150–60. http://dx.doi.org/10.22270/jddt.v14i6.6641.

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Apalutamide is an anti-cancer agent used for the management of prostate cancer. A new stability indicating RP-HPLC method (Gradient mode) has been developed for the estimation of Apalutamide and its related substances using Waters Alliance system (Model no. 2996 and 2695) with Inertsil ODS-3 (250 × 4.6 mm, 5μm) column (PDA detector) was used for the present study. A mixture of Ammonium phosphate buffer solution and Acetonitrile (30: 70, v/v) was used as the mobile phase for the chromatographic study (Flow rate: 1.0 mL/min; Detection wavelength: 243 nm). Stress degradation studies were performe

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Dr., A. Madhukar *. Juveriya Asrar Mariyam Adiba Sultana Shehnaz Begum. "A SIMPLE UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CARVEDILOL IN BOTH BULK AND MARKETED DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 03 (2019): 6920–25. https://doi.org/10.5281/zenodo.2616682.

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<em>The present work was to develop two simple UV spectrophotometric methods for simultaneous estimation of Carvedilol (CAR) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Carvedilol. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.69% and 100.82% respectively. The methods we

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Chavhan, Vinit. "DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHODS AND VALIDATION FOR ESTIMATION OF SIMVASTATIN IN BULK AND TABLET DOSAGE FORM BY ABSORBANCE MAXIMA AND AREA UNDER THE CURVE METHOD." Journal of Applied Pharmacy 6 (2014): 55. http://dx.doi.org/10.21065/19204159.6.55.

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S Malviya, A Gour, Ram Singh Bishnoi, and R Dahima. "Forced Degradation Studies of Stigmasterol: Development of Stability Indicating Hptlc Method and I’ts Validation as Per Ich Guidelines." Journal of Advanced Zoology 44, S6 (2023): 1467–76. http://dx.doi.org/10.17762/jaz.v44is6.2499.

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Background - Forced degradation is a method for determining the stability of pharmaceuticals so that stable formulations can be developed & the shelf life of pharmaceuticals can be predicted. During force degradation studies in pharmaceuticals, this research describes the characterization of generated contaminants and mechanism of formation. Forced degradation studies are used in the early stages of pharmaceutical development to ensure that the final products are stable. The goal of herbal drug stability testing is to give data on how much quality of the herbal products changes over time a

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M, Amjad. "A Comprehensive Review on HPLC Method Development, Validation, Optimization in Pharmaceuticals." Open Access Journal of Waste Management & Xenobiotics 6, no. 3 (2023): 1–9. http://dx.doi.org/10.23880/oajwx-16000188.

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The analytical method development in Pharmaceuticals is most important because it is the regulatory requirements. The determination of Active Ingredients of Pharmaceuticals (API) and Excipients is only possible when the testing method will be validated as per ICH, WHO guidelines or GMP requirements. The development will be reliable when the correct and precise strategy will be followed. Here, the systematic method development technique and validation parameters have been discussed precisely. This comprehensive review will be very helpful for analysts to develop analysis method of new molecules

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Godge, Rahul K., Soniya S. Satpute, and Magar M. Sagar. "Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 212–22. http://dx.doi.org/10.22270/jddt.v9i3-s.2827.

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A method was developed and validated for analysis of Formoterol Fumarate and Fluticasone Propionate in dry powder inhaler formulations. Separation was achieved on a HiQ Sil C18HS, 250×4.6 mm, 5 µm column using a mobile phase consisting of Acetonitrile: 0.01 M Ammonium Dihydrogen Phosphate solution (80:20 %v/v) at a flow rate of 1ml/min PDA detection at 215.0 nm. This method is validated according to ICH guidelines, which include linearity, precision, accuracy, specificity, robustness. The result obtained were within the acceptance criteria as per ICH guidelines. Keywords: formoterol fumarate d

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Satpute, Soniya S., P.D. Dighe, Rahul K. Godge, Arshu A. Patel, and Kiran K. Shinde. "Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation." Journal of Advances in Bio- pharmaceutics and Pharmacovigilance 1, no. 2 (2019): 9–33. https://doi.org/10.5281/zenodo.3361994.

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<em>A method was developed and validated for analysis of Formoterol Fumarate and Fluticasone Propionate in dry powder inhaler formulations. Separation was achieved on a HiQ Sil C18HS</em><em>, 250×4.6mm</em><em>, 5µm column using a mobile phase consisting of Acetonitrile: 0.01 M Ammonium Dihydrogen Phosphate solution (80:20 %v/v) at a flow rate of 1ml/min PDA detection at 215.0 nm. This method is validated according to ICH guidelines, which include linearity, precision, accuracy, specificity, robustness. The result obtained were within the acceptance criteria as per ICH guidelines.

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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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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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J., Kalpana, and Himaja M. "Simultaneous quantitation of corticosteroid drugs with their specified impurities using liquid chromatography." Journal of Indian Chemical Society Vol. 92, Apr 2015 (2015): 585–88. https://doi.org/10.5281/zenodo.5596996.

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Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University, Vellore-632 014, Tamilnadu, India <em>E-mail</em> : drmhimaja@gmail.com A rapid stability proving HPLC method was developed and validated for the estimation of the corticosteroid drugs in combination drug product. The chromatographic separation of betamethasone acetate and betamethasone sodium phosphate and five specified impurities were achieved with Hypersil BDS phenyl column (250 × 4.6 mm, 5 µm) with mobile phase consisting of water and acetonitrile (67 : 38 v/v) using 1 mL/min flow rate (UV detectio

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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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Gholve, Sachin, Sharddha Gangapure, Mahesh Birajdar, Imran Mujewar, and Omprakash G. Bhusnure. "RP-HPLC Method Development and Validation for Determination of Didanosine in Pharmaceutical Dosage Forms." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 343–47. http://dx.doi.org/10.22270/jddt.v9i4-s.3328.

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To develop a simple, cheap, accurate, and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for estimation of Didanosine in pharmaceutical dosage forms. The separation was conducted by using mobile phase consisting of methanol: water in the ratio (30:70). The wavelength was found at 246nm. Agilent 1220 Infinity LC with ezchrome software is used for chromatographic determination. The separation was conducted by using Zebra Eclipse XDB-C-18 (4.6×250×5µm) at the flow rate of 1.0 ml/min using variable wavelength detector. The developed

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Lalka, Shaily, Munira Momin, and Atul Sherje. "SIMULTANEOUS ESTIMATION OF BERBERINE HYDROCHLORIDE AND INDOMETHACIN FOR IN VITRO DIFFUSION PROFILE BY UV SPECTROSCOPY." INDIAN DRUGS 58, no. 02 (2021): 26–30. http://dx.doi.org/10.53879/id.58.02.11532.

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The present work aims to develop a precise, accurate and validation method to estimate berberine hydrochloride and indomethacin in gel formulations. In the present work, 50% phosphate buffer pH 7.4, 25% methanol and 25% ethanol blend was used as a solvent to increase the solubility of both the drugs. The analytical wavelength for berberine hydrochloride and indomethacin was 343 nm and 316nm, respectively. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness as per the ICH guidelines. The validated method was then applied in the

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Lal, Basant, Manish Jaimini, and Devesh U. Kapoor. "DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CLARITHROMYCIN, TINIDAZOLE AND LANSOPRAZOLE IN FIXED DOSE COMBINATIONS." Tropical Journal of Pharmaceutical and Life Sciences 8, no. 4 (2021): 01–10. https://doi.org/10.61280/tjpls.v8i4.69.

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New RP-HPLC method was developed for the simultaneous estimation of Clarithromycin, tinidazole and lansoprazole in the fixed dose combination (PYLOKIT by CIPLA). RP-HPLC separation was carried out using Ultisil XB-CN column (250 x 4.6 mm) internal diameter and the packing material having 5µm size) using gradient mobile phase of Potassium dihydrogen phosphate: acetonitrile. 1 mL/min was the flow rate and UV detector at 210 nm wavelength was fixed for detection of the drug. The method validation was done as per ICH guideline and the parameters were included such as accuracy, precision specificit

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Chandan, Nakum*¬ Harpal Makwana Vaishali Karkhanis Hina Bagada. "Stability Indicating Assay Method Development and Validation of HPTLC Method for Estimation of Prochlorperazine maleate in Bulk and Tablet Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 1957–72. https://doi.org/10.5281/zenodo.15057985.

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Prochlorperazine maleate is an Antiemetic and Antipsychotic Tranquilizer. It is used for the treatment of severe nausea and vomiting, as well as short-term management of psychotic disorders such as generalized non-psychotic anxiety and schizophrenia. An extensive literature surveys reveals that various analytical methods have been reported for the estimation of Prochlorperazine maleate in API and pharmaceutical dosage form. So, it was thought to develop simple, precise, accurate and specific stability indicating HPTLC method for the estimation of Prochlorperazine maleate in API & pharmaceu

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Dalvi, Sampada D., Pramod L. Ingale, and Sanjay M. Dalvi. "DEVELOPMENT AND METHOD VALIDATION OF STABILITY INDICATING ASSAY METHOD OF DUTASTERIDE BY USING UV-VIS SPECTROSCOPY." INDIAN DRUGS 57, no. 12 (2021): 36–40. http://dx.doi.org/10.53879/id.57.12.11575.

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The objective of the present study was to develop and validate stability indicating method to generate reliable, precise, cost effective UV-VIS spectroscopy method and accurate data for dutasteride regardless of whether it is for acceptance, release, stability or pharmacokinetic study. The solvent used was methanol and the absorption maximum λ max of the drug was found to be at 241nm. A linear response was observed in the range of 1-100µg/ml. Linear regression of absorbance on concentration gave the equation y = 0.0194x + 0.0099 with a regression co-efficient (R2) of 0.997. The method was then

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Pooja, Eknathji Waware, Dattatriayji Jolhe Anuja, Rajendra Lilhare Swati, Prakash Jumade Prasad, and Ramgopalji Mundhada Dharmendra. "Development and validation of simultaneous estimation of drugs in combination from pharmaceutical formulation by RP-HPLC method." GSC Biological and Pharmaceutical Sciences 12, no. 3 (2020): 155–65. https://doi.org/10.5281/zenodo.4266015.

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Metformin is recommended as a first-line agent for monotherapy and combination therapy for patients with type 2 diabetes mellitus (T2DM). Patients whose glycaemic control deteriorates over time with metformin monotherapy will require additional anti-diabetic medication. The development of HPLC method for simultaneous estimation of anti-diabetic drugs in combination from solid dosage form by HPLC method. To validate the developed HPLC method as per ICH guidelines. The System suitability test ,Capacity factor, Tailing factor, Resolution, Selectivity,  Separation factor, Theoretical plates,

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Dr., Amit Gosar, Shaikh Tabrez, and Joglekar Amit. "Development of a highly sensitive method for quantitative estimation of Hexamine impurity in Febuxostat drug substances using LC-MS." Research & Review: Drugs and Drugs Development 1, no. 1 (2019): 32–36. https://doi.org/10.5281/zenodo.2588123.

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<em>A selective and highly sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed for the determination of Hexamine impurity in Febuxostat drug substance. The method was validated as per International Council for Harmonisation (ICH) guidelines, for which limit of detection and limit of quantitation obtained were 0.75 ppm and 2.26 ppm respectively. The regression coefficient found for the linearity study was 0.9984. The % recovery of the spiked hexamine in drug substance obtained was in the range of 81.9 to 110.5 ensured the accuracy of the method. The method can be adap

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Gupta, Pratik Kumar, and Vibha Chaturvedi. "A STUDY ON FORCED DEGRADATION AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF BENZALKONIUM CHLORIDE IN AZELASTINE HYDROCHORIDE PHARMACEUTICAL OPHTHALMIC FORMULATION." Asian Journal of Pharmaceutical and Clinical Research 10, no. 11 (2017): 374. http://dx.doi.org/10.22159/ajpcr.2017.v10i11.21701.

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Objective: This study was designed to conduct forced degradation and validation studies for determination the benzalkonium chloride (BKC) as major homologues form in azelastine hydrochloride pharmaceutical ophthalmic formulation by a novel stability indicating reverse phase high-performance liquid chromatographic method (RP-HPLC).Methods: Forced degradation study and validation were carried out with a analytical approach of reverse phase chromatographic analysis with C18, cosmosil (250mm x 4.6mm i.d. x 5μm) column using mobile phase consisting acetonitrile – buffer of pH 5.0 with 5N NaOH (45:5

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Rudrapal, Mithun, and Nazim Hussain. "Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC." Journal of Drug Delivery and Therapeutics 10, no. 4 (2020): 97–101. http://dx.doi.org/10.22270/jddt.v10i4.4217.

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A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good

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M., Mukkanti Eswarudu* A. Lakshmana Rao K. Vijay. "STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF EZETIMIBE AND GLIMEPIRIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 11 (2018): 11268–77. https://doi.org/10.5281/zenodo.1476653.

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<em>A simple, specific, </em><em>accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method and Stability indicating tests was developed and validated for the simultaneous quantification of Ezetimibe and Glimepiride in Bulk drugs and Pharmaceutical dosage form. The quantification is carried out using Kromosil C</em><em>18</em><em> (150 ×4.6mm, 5µ) column </em><em>with </em><em>mobile phase consisted of </em><em>a mixture of </em><em>Acetonitrile and Potassium dihydrogen ortho phosphate buffer in the ratio of 65:35 (v/v) delivered at a flow rate of

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B.Chitra, *. and T. K. Ravi. "DEVELOPMENT OF VALIDATED RP - HPLC METHOD FOR THE DETERMINATION OF ZIPRASIDONE HYDROCHLORIDE IN CAPSULE DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 07 (2018): 6778–83. https://doi.org/10.5281/zenodo.1321261.

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This study presents a simple and rapid RP – HPLC method for the determination of ziprasidone hydrochloride in capsule dosage form. To optimize the chromatographic condition, the mobile phase system employed was potassium dihydrogen orthophosphate: ACN: methanol in the ratio of 30:70% v/v. The pH was adjusted to 4.9.The flow rate was maintained at 1ml /min.The developed method was validated for linearity, accuracy, precision, LOD and LOQ and recovery as per the ICH guidelines.Good linearity was obtained over the concentration ranges of 1-10 μg/ml. The percentage recovery was more than

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Bandaru, Nagaraju, Naga Venkata Indira Devi Jajula, Prashik B. Dudhe, et al. "Stability Indicating RP-HPLC Method Development and Validation for Quantification of Favipiravir and its Related Substances." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1449–54. http://dx.doi.org/10.25258/ijpqa.15.3.55.

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Background: Favipiravir is an influenza antiviral medication. DEM Avigan is the commercial name for a pyrazine carboxamide derivative. Aim: According to the guidelines framed by ICH - International Council for Harmonisation, the present method was developed and validated for the system suitability, specificity, linearity, precision, limit of quantification and limit of detection, accuracy, & robustness. Results: All the results obtained were within the acceptable range. This method was used to better separate the peaks of Favipiravir and its three impurities. The retention times and square

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G., Sirisha* M. Gayathri Devi M. Gowri Manoja G. Sudhakar. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TRABECTEDIN IN BULK AND PARENTERAL DOSAGE FORM BY RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 03 (2018): 1642–48. https://doi.org/10.5281/zenodo.1208619.

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A new RP-HPLC method for the quantitative determination of Trabectedin was developed and validated as per ICH guidelines. The drugs were injected into Zorbax SB, C18,(150x4.6mm); 3.5µm column maintained at ambient temperature and effluent monitored at 215nm. The mobile phase consisted of phosphate buffer (pH 3.0) and Acetonitrile in the ratio of 70:30 V/V. The flow rate was maintained at 0.8 ml/min. The calibration curve for Trabectedin was linear from 50-175µg/ml (r 2 for Trabectedin = 1 ). The proposed method was adequate, sensitive, reproducible, accurate and precise for the det

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Chandran, Sajith Kumar Chandran. "A Review on the HPLC Method Development and Validation Studies of Combined Dosage Form of Rosuvastatin and Ezetimibe." Asian Journal of Pharmaceutical Research and Development 12, no. 4 (2024): 108–12. http://dx.doi.org/10.22270/ajprd.v12i4.1449.

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Analytical method development is an important aspect of drug development and manufacturing. An exceptional analytical method is the one which detects the active pharmaceutical ingredients as well as the impurities and other chemical entities which invariably enters the formulations due to various reasons. The methods which are developed accordingly are to be validated as per the ICH guidelines so as to be accepted in a commercial setting. Coronary Artery Disease is a life threatening condition, which affects millions of people, where the blood flow to the heart is affected due to plaque deposi

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Krishnamanjari, A. Pawar, Ch Srujani, K. Roshini, and K. S. Nataraj. "Implementing Quality by Design approach in Analytical Reverse Phase High Performance Liquid Chromatography Method Development and Validation for the Determination of Fedratinib." International Journal of Pharmaceutical Sciences and Drug Research 13, no. 03 (2020): 253–62. http://dx.doi.org/10.25004/ijpsdr.2021.130303.

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A novel, accurate, precise, specific, sensitive, and robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Fedratinib using the analytical quality by design (AQbD) approach mentioned in International Council for Harmonisation (ICH) Q8 (R2) guidelines. By implementing QbD in HPLC methods, ruggedness and robustness will be verified early in the stage of method development to ensure the method's performance over the product's lifetime. Design Expert® (12.0.12.0) modeling software (Stat-Ease Inc., Minneapolis, MN, USA) was

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Sachin, Bhusari* Pritesh Jawale Pravin Wakte. "Development and Validation of Reverse-Phase High-Performance Liquid Chromatography Method for Estimation of Dapagliflozin in Bulk and Formulation." International Journal in Pharmaceutical Sciences 1, no. 10 (2023): 78–84. https://doi.org/10.5281/zenodo.8428473.

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A new, simple, rapid, accurate and precise high-performance thin layer chromatography (HPLC) method has been developed and validated according to the guidelines of the International Conference on Harmonization (ICH Q2(R1) for the estimation of dapagliflozin in bulk and formulation. The chromatographic analysis was performed by an Agilent HPLC instrument using a BDS Hypersil, C-18, 250mmx4.6mm, 5 μm and mobile phase comprising 0.1% ortho-phosphoric acid in water and acetonitrile (65:35 v/v) at flow rate of 1.0 ml/min. The eluent was monitored at 225 nm for determination of dapagliflozin. The

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Chiarentin, Lucas, Catarina Cardoso, Margarida Miranda, and Carla Vitorino. "Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation." Pharmaceutics 15, no. 7 (2023): 1810. http://dx.doi.org/10.3390/pharmaceutics15071810.

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Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is a dire need to take a step forward in rheology method development and validation procedures. This paper aims to apply Analytical Quality by Design (AQbD) principles towards the develo

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*Harini, Uppada, Boddapu Divya, and Bonula Harshini. "DEVELOPMENT AND VALIDATION OF A UV SPECTROSCOPIC METHOD FOR DETERMINATION OF SOTAGLIFLOZIN." World Journal of Pharmaceutical Science and Research 4, no. 3 (2025): 114–20. https://doi.org/10.5281/zenodo.15561449.

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<strong>Background and Objective:</strong><strong> </strong>Sotagliflozin is recommended for patients to reduce the risk of heart failure, type 2 diabetes and chronic kidney diseases. Since there were no analytical methods reported for the estimation of Sotagliflozin till date, the present work aims to develop and validate a UV spectrophotometric method for the evaluation of Sotagliflozin in bulk. <strong>Method: </strong>By using Lab India UV spectrophotometer, the standard solution was scanned against blank in the range of 200-400 nm and the λ max was determined using UV Analyst softw

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Mounika, Gudipally, K. Bhavya Sri, R. Swethasri, and M. Sumakanth. "Research Article on Development and Validation of RP-HPLC Method for Estimation of Canagliflozin." SAMRIDDHI : A Journal of Physical Sciences, Engineering and Technology 11, no. 02 (2019): 85–92. http://dx.doi.org/10.18090/samriddhi.v11i02.2.

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To develop an accurate, precise, specific high performance liquid chromatography method for quantification of Canagliflozin in bulk and dosage forms. A C18 column (250mm X 4.6mm; 5μm phenomenex) was used with mobile phase containing Acetonitrile-0.1% sodium acetate buffer (pH-4.6), (20:80) in isocratic mode. The flow rate maintained was 1.0ml/min and the U.V detector was operated at 291nm. The retention time of Canagliflozin was 3.307min and showed a good linearity in concentration range of 2-14μg/ml with correlation coefficient of 0.999. The average percent recovery was found to be 99.98%. Th

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DHARMAMOORTHY, G. "SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN AND HYDROCHLORTHIAZIDE IN HUMAN PLASMA BY RPHPLC METHOD." YMER Digital 21, no. 07 (2022): 796–816. http://dx.doi.org/10.37896/ymer21.07/64.

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A new simple and precise stability indicating bioanalytical reverse-phase High Performance Liquid Chromatography (RP-HPLC) method was developedand validated for the simultaneous estimation of Eprosartan and Hydrochlorothiazidein their formulation and in human plasma.The developed method was successfully used for assaying drug contents in plasma. Isocratic elution mode was carried at Symmetry C 18 (150mm x 4.6 mm, 5) column using 0.1% Orthophosphoric acidpH (2.2): Acetonitrile (65:35v/v) as mobile phase at flow rate 1.0mlmin at detection wavelength 240 nm. Valsartan was taken as an internal st

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Ashish, Jain* Srushti Kadave Mukesh Patil Rupali Bothara Swati Borase. "Development and Validation of Metaxalone and Diclofenac Potassium in Bulk and Its Formulation using RP-HPLC Techniques." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 2120–31. https://doi.org/10.5281/zenodo.14481671.

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This research article aims to develop and validate the Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) technique for the simultaneous determinations of Diclofenac potassium and Metaxalone in tablets and bulk. On an Eclipse plus C<sub>18</sub> (250 mm × 4.6 mm ID, 5μm) column, chromatographic separation was accomplished with a mobile phase consisting of potassium dihydrogen phosphate buffer (pH 4.2): acetonitrile (30:70 v/v) at a flow rate of 1 ml/min. The detection wavelength was selected to be 280 nm. Diclofenac potassium and Metaxalone were shown to have retention per

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