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Journal articles on the topic 'Forced Degradation Method'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

Mladenovic, Aleksandar, Milka Jadranin, Aleksandar Pavlovic, et al. "Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products." Chemical Industry and Chemical Engineering Quarterly 21, no. 3 (2015): 447–55. http://dx.doi.org/10.2298/ciceq141023047m.

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This study describes the investigation of degradation products of donepezil (DP) using stability indicating RP-HPLC method for determination of donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. In order to investigate the stability of drug and formed degradation products, a forced degradation study of drug sample and finished product under different forced degradation conditions has been conducted. Donepezil hydrochloride and donepezil tablets were subjected to stress degradation conditions recommended by International Conference on Harmonization (ICH). Donepezi

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Mehta, Tushar N., Atul K. Patel, Gopal M. Kulkarni, and Gunta Suubbaiah. "Determination of Rosuvastatin in the Presence of Its Degradation Products by a Stability-Indicating LC Method." Journal of AOAC INTERNATIONAL 88, no. 4 (2005): 1142–47. http://dx.doi.org/10.1093/jaoac/88.4.1142.

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Abstract A forced degradation study was successfully applied for the development of a stability-indicating assay method for determination of rosuvastatin Ca in the presence of its degradation products. The method was developed and optimized by analyzing the forcefully degraded samples. Degradation of the drug was done at various pH values. Moreover, the drug was degraded under oxidative, photolytic, and thermal stress conditions. Mass balance between assay values of degraded samples and generated impurities was found to be satisfactory. The proposed method was able to resolve all of the possib

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Sonawane, S. S., P. B. Badhan, J. P. Warungse, and A. R. Shaikh. "MICROWAVE-ASSISTED FORCED DEGRADATION AND DEVELOPMENT OF A VALIDATED STABILITY-INDICATING RP-HPLC METHOD FOR VENLAFAXINE IN BULK AND CAPSULE FORMULATION." INDIAN DRUGS 53, no. 02 (2016): 47–52. http://dx.doi.org/10.53879/id.53.02.10343.

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A stability-indicating RP-HPLC method was developed and validated for venlafaxine in bulk and capsule formulation in the presence of its degradation products, generated from forced degradation studies. Venlafaxine was subjected to forced degradation under acid, alkali, wet heat, dry heat, oxidative conditions and photolytic conditions. In addition, acid, alkali and wet heat degradation was performed using microwave oven to substitute conventional degradation technique of using heating mantle with microwave oven; provided it proved that similar degradation products were obtained under microwave

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Gopika, V. C., M. S. Hisana, V. Jayakrishnan, et al. "Degradation study of Doxycycline in bulk and formulation by UV-Visible spectrophotometry." World Journal of Biology Pharmacy and Health Sciences 15, no. 2 (2023): 067–73. https://doi.org/10.5281/zenodo.10676996.

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<strong>Introduction:</strong> Forced degradation is a process that involves degradation of drug products and drug substances at condition more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. <strong>Aim and objective: </strong>To investigate the forced degradation study for the determination of degradation of Doxycycline by UV-Visible spectrophotometric method. <strong>Methods: </strong>Doxycycline sample and standard were exposed to different stress conditions (hydrolytic and oxidative d

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Nageswara Rao Jakkam, Sudhakar Chintakula, and Sreenivasa Rao Battula. "Studies on forced degradation and solid state stability of tenofovir disoproxil orotate." International Journal of Research in Pharmaceutical Sciences 12, no. 4 (2021): 2485–91. http://dx.doi.org/10.26452/ijrps.v12i4.4891.

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In order to develop a stability regulatory system for drug substances and degraded products, a forced degradation study is an essential part in the design of the method. As per ICH Guidelines Q1A in 1993, it was established as an essential requirement for the regulatory system to assess the stability of drugs and their degradation products under the degradation studies by force. These analytical methods are helpful in the development of stability, indicating the method by conducting the studies on forced degradation with their mechanism of degradation. Drug products by degradation and new drug

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Gopika V C, Hisana M S, Jayakrishnan V, et al. "Degradation study of Doxycycline in bulk and formulation by UV-Visible spectrophotometry." World Journal of Biology Pharmacy and Health Sciences 15, no. 2 (2023): 067–73. http://dx.doi.org/10.30574/wjbphs.2023.15.2.0328.

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Introduction: Forced degradation is a process that involves degradation of drug products and drug substances at condition more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Aim and objective: To investigate the forced degradation study for the determination of degradation of Doxycycline by UV-Visible spectrophotometric method. Methods: Doxycycline sample and standard were exposed to different stress conditions (hydrolytic and oxidative degradation). Both standard drug and marketed formulations were use

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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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Sahil, Mansuri, Vaishnav Rajat, and Goyal Anju. "Comparison of Analytical Parameters Required for Validation Forced Degradation Studies." Pharmaceutical and Chemical Journal 8, no. 3 (2021): 97–109. https://doi.org/10.5281/zenodo.13963057.

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Force degradation studies or stress testing are commonly employed in pharmaceutical industries in order to develop a stability indicating method (SIM). In forced degradation studies, drug substance (API) or a drug product is subjected to various extremities of pH, humidity, hydrolysis and oxidation, photolytic and thermal conditions which in turn produce various degrading products known as degradants. This gives an understanding about the degradation pathways of drug substance and drug products. International Conference on Harmonization (ICH) guidelines Q1A, Q1B, Q2B, Q3A and Q3B regulate the

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Sharma, Ritesh, and Shyam Pancholi. "RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions." Acta Pharmaceutica 60, no. 1 (2010): 13–24. http://dx.doi.org/10.2478/v10007-010-0010-2.

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RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditionsA simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C18column with the mobile phase composed of methanol, acetonitrile and water (60:15:25,V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range o

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Manjrawala, Mitali, Srinivasarao V. N. Divvela, and Rakesh Kumar. "Validated RP-HPLC Stability Indicating Method of Anti-Diabetic Active Pharmaceutical Ingredient; Saxagliptin Hydrochloride Dihydrate." DER PHARMA CHEMICA 13, no. 3 (2021): 5. https://doi.org/10.5281/zenodo.11071036.

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A simple and precise stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of related substances of Saxagliptin drug substance. The method was developed to separate possible degradation and process related impurities. Chromatographic condition was carried out on in Zorbax SB-C8, 150 mm x 4.6 mm, 5µm HPLC column with prepared buffer solution 1.0 ml of ortho phosphoric acid mixed with 0.1% of sodium dihydrogen phosphate solution, mix buffer solution and acetonitrile in ratio of 70:30(%v/v) used as mobile

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Manjrawala, Mitali, N. Divvela Srinivasarao V, and Rakesh Kumar. "Validated RP-HPLC Stability Indicating Method of Anti-Diabetic Active Pharmaceutical Ingredient; Saxagliptin Hydrochloride Dihydrate." Der Pharma Chemica 13, no. 3 (2021): 5. https://doi.org/10.5281/zenodo.14722741.

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A simple and precise stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of related substances of Saxagliptin drug substance. The method was developed to separate possible degradation and process related impurities. Chromatographic condition was carried out on in Zorbax SB-C8, 150 mm x 4.6 mm, 5µm HPLC column with prepared buffer solution 1.0 ml of ortho phosphoric acid mixed with 0.1% of sodium dihydrogen phosphate solution, mix buffer solution and acetonitrile in ratio of 70:30(%v/v) used as mobile

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Yohan, Talari, and Sunitha Reddy M. "A Brief Study on Forced Degradation Studies with Regulatory Guidance." A Brief Study on Forced Degradation Studies with Regulatory Guidance 8, no. 10 (2023): 8. https://doi.org/10.5281/zenodo.10021615.

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Forced degradation studies is a stability indicating analytical method to identify the pathway of degradation of both drug molecule and product by applying various stress testing conditions than accelerated conditions. As stress degradation study is made compulsory by various countries food and drug agencies for regulatory and market approval of both "Branded drugs and Generic drugs" and products respectively. After introduction of ICH guidelines in 1993, worldwide attention gained by stress degradation evaluation report. Hence we provide a brief overview on the force degradation procedure, me

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Verma, Akanksha, Shivali Singla, and Priyankul Palia. "The Development of Forced Degradation and Stability Indicating Studies of Drugs- A Review." Asian Journal of Pharmaceutical Research and Development 10, no. 2 (2022): 83–89. http://dx.doi.org/10.22270/ajprd.v10i2.1104.

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Force degradation study is an essential study that provides the knowledge & judgement to develop a stability indicating analytical method. This study helps to establish the specification and shelf life of a drug substance or drug product. Force degradation study show the chemical behaviour of the molecule which in turn helps in the development of formulation and package. This helps to describe the analytical methods helpful for development of stability indicating method. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation st

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Y.Neelima, and Y.Kranthi Kumar*. "STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF LINAGLIPTIN IN BULK AND TABLET DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 07 (2018): 6512–18. https://doi.org/10.5281/zenodo.1312597.

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The Reverse Phase High Performance Liquid Chromatographic method was developed for the determination of linagliptin with its stability studies in its bulk and pharmaceutical dosage form which was precise, accurate and sensitive. The separation has been done by using the chromatographic conditions on an Inertsil ODS column (250 x 4.6 mm, 5µ particle size), the mobile phase of potassium dihydrogen phosphate buffer pH 6 and acetonitrile in the ratio 60:40 v/v, at a flow rate of 1 mL/min at an ambient temperature at a wavelength 246 nm at retention time of 3.67 minutes. The method developed

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Sarif, Niroush Konari, T. Jacob Jane, and Prakash Vipin. "Stability Indicating UV Spectrophotometric Method For Linagliptin and Metformin in Pharmaceutical Dosage Form." Pharmaceutical Methods 8, no. 2 (2017): 01–06. https://doi.org/10.5281/zenodo.14855540.

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Introduction: Linagliptin and metformin are newly introduced FDA drug combination for the treatment type 2 diabetic patients.This study reveals the development of three methods for the UV spectrophotometric simultaneous estimation of linagliptin and metformin in pharmaceutical dosage and forced degradation studies on four different stress conditions. Methods: Development of method was based upon simultaneous equation,absorbance ratio and absorbances correction method with a simple solvent system of distilled water. Absorption maxima was found to be 230.4nm, 294.4nm for metformin and linoglipti

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Michail, Karim, Hoda M. Daabees, Youssef Beltagy, Magdi Abdel-Khalek, and Mona M. Khamis. "Stress Degradation Assessment of Lamotrigine Using a Validated Stability-Indicating HPTLC Method." Journal of Chemistry 2013 (2013): 1–6. http://dx.doi.org/10.1155/2013/608196.

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In this work, a sensitive and stability-indicating HPTLC method for the determination of lamotrigine is presented. According to the International Conference on Harmonization guidelines Q1A, lamotrigine was exposed to a variety of stress conditions; these include heating in acidic, basic and neutral media. Its stability towards oxidative stress, humidity, high temperature and direct sunlight was also examined. Separation of the drug from its forced degradation impurities was achieved using TLC silica gel plates and a mobile phase composed of ethyl acetate: methanol: ammonia. The linear regressi

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Madala, Anuradha* Keerthisikha Palur. "A NEW STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN TABLET DOSAGE FORM." Indo American Journal of Pharmaceutical Sciences (IAJPS) 03, no. 09 (2016): 953–59. https://doi.org/10.5281/zenodo.153858.

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In the present work, an attempt was made to provide a newer, sensitive, simple, accurate and reproducible stability indicating RP- HPLC method.. The optimum wavelength for detection was 256 nm at which better detector response for drug was obtained. The average retention time for Rosuvastatin and Fenofibrate was found to be 2.006 and 3.856 min respectively. System suitability tests are an integral part of chromatographic method. They are used to verify the reproducibility of the chromatographic system. To ascertain its effectiveness, system suitability tests were carried out on freshly prepare

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Kovačić, Jelena, Daniela Amidžić Klarić, Nikša Turk, Željko Krznarić, Emma Riordan, and Ana Mornar. "The Stability-Indicating Ultra High-Performance Liquid Chromatography with Diode Array Detector and Tandem Mass Spectrometry Method Applied for the Forced Degradation Study of Ritlecitinib: An Appraisal of Green and Blue Metrics." Pharmaceuticals 18, no. 1 (2025): 124. https://doi.org/10.3390/ph18010124.

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Background/Objectives: Janus kinase inhibitors open new horizons for small-molecule drugs in treating inflammatory bowel disease, with ritlecitinib demonstrating significant efficacy in clinical trials for ulcerative colitis and Crohn’s disease. Ritlecitinib, a second-generation JAK3 inhibitor, is a novel therapeutic agent for alopecia areata and other autoimmune conditions. Methods: A new stability-indicating UHPLC-DAD-MS/MS method was developed, validated, and applied for a forced degradation study of ritlecitinib under ICH guidelines. Results: The method demonstrated high specificity, sensi

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Kavitha., K. 1. *. Kumar. P. 1. Manjula Devi A.S 2. "STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF THIOCOLCHICOSIDE IN PARENTERAL DOSAGE FORMS." Journal of Scientific Research in Pharmacy 7, no. 7 (2018): 84–91. https://doi.org/10.5281/zenodo.1326519.

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<strong><em>ABSTRACT</em></strong> <strong><em>A</em></strong><em> rapid, simple, precise stability indicating RP-HPLC method for the determination of thiocolchicoside on C18 column (250mm × 4.0mm, 5µm) have been developed. A mobile phase consisting of ammonium acetate: methanol (50:50) was used. The flow rate was 0.8ml/min by UV detection at 256 nm. The specificity of the method was ascertained by forced degradation studies by alkali, acid degradation and oxidation, photolysis. Beer law was obeyed over the range of 1-10µg/ml, correlation co efficient as 0.9996. This method w

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Bhardwaj, Shalini, M. K. Gupta, and V. Bhalla. "METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE." International Journal of Drug Regulatory Affairs 3, no. 4 (2018): 24–42. http://dx.doi.org/10.22270/ijdra.v3i4.174.

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A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was performed on a Sunniest C-18-HT, 2m, (50 2.1nm) column with gradient elution. For UPLC method, UV detection was made at 335nm. During method validation, parameters such as precision, linearity, stability, robustness and specificity were evaluated, which remained within acceptable limits. Forced degradation studies of Nifedipine were studied under acidic and alkaline stress condition

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Rashmitha, N., T. Joseph Sunder Raj, Ch Srinivas, et al. "A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium." E-Journal of Chemistry 7, no. 2 (2010): 555–63. http://dx.doi.org/10.1155/2010/156593.

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The present paper describes the development of a reverse phase chromatographic (RPLC) method for montelukast sodium in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of montelukast sodium was observed under acid and oxidative environment. The drug was found to be stable in other stress conditions studied. Successful separation of the drug from the process impurities and degradation products formed under stress co

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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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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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Yeluri, Ramachandra Reddy, BV Subba Reddy, R. Ratna Kumari, and Ganji Jai Venkateswara Rao. "QUANTIFICATION OF PREGABALIN AND ETORICOXIB COMBO IN TABLETS AND BULK WITH DEVELOPED RP-HPLC METHOD: STABILITY INDICATING FEATURE ASSESSMENT." Journal of Advanced Scientific Research 13, no. 04 (2022): 31–36. http://dx.doi.org/10.55218/jasr.202213405.

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This investigation reports a stability indicating HPLC method to quantify Pregabalin (PGBN) and etoricoxib (ERCB) in tablets form and bulk form. The PGBN and ERCB were quantified on Thermo C18 column with Orthophosphoric acid (0.1%), and methanol 60:40 vol/vol ratio was employed as mobile phase. The amounts of PGBN and ERCB were enumerated by detector fixed at 236 nm. The procedure demonstrated reasonable linearity for PGBN with R2 = 0.9998 in the quantity scale 37.5 to 112.5 µg/ml, and for ERCB with R2 = 0.9999 in the quantity scale 30 to 90 µg/ml. The LOD as well as LOQ for PGBN are 0.201µg/

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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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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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Sahil, Mansuri, Vaishnav Rajat, and Goyal Anju. "The Study of Impact of Forced Degradation on the Assay of Methylene Blue by RP-HPLC." Pharmaceutical and Chemical Journal 8, no. 5 (2021): 32–41. https://doi.org/10.5281/zenodo.13963626.

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The main objective of this study is to study the impact of forced degradation on the assay of Methylene Blue by RP-HPLC. A simple, specific, accurate and precise RP-HPLC method has been validated as per ICH guideline for determination of assay of Methylene Blue. Validation parameters like Linearity, Accuracy, Precision, System suitability, Specificity were tested. The Methylene Blue was dissolved in HPLC water at the concentration of 1 mg/mL and appropriate chromatographic condition was kept as per the monograph of Methylene Blue in USP. No interference was observed in the parameter specificit

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M., B. V. Narayana, B. Chandrasekhar K., and M. Rao B. "A validated specific stability-indicating RP-HPLC method for Aripiprazole and its related substances." Journal of Indian Chemical Society Vol. 91, Mar 2014 (2014): 439–47. https://doi.org/10.5281/zenodo.5717610.

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Matrix Laboratories Private Limited, Hyderabad-500 078, India <em>E-mail</em> : balajimachireddy@gmail.com Department of Chemistry, Jawaharlal Nehru Technological University Anantapur, Anantapur-515 002, Andhra Pradesh, India Director, Analytical R&D, Johnson and Johnson Ltd., Mumbai, India <em>Manuscript received online 12 May 2012, revised 26 June 2012, accepted 20 July 2013</em> A validated specific stability indicating reversed-phase liquid chromatographic method was developed for the quantitative determination of Aripiprazole and its related substances in bulk samples, pharmaceutical

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Bhaskar, Rajveer, Monika Ola, Vinit Agnihotri, Arjun Chavan, and Harpalsing Girase. "Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s." Journal of Drug Delivery and Therapeutics 10, no. 2-s (2020): 149–55. http://dx.doi.org/10.22270/jddt.v10i2-s.4040.

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The stability of a new drug substances and new drug products is a vital parameter which may affect purity, safety & potency. Changes in drug stability can threat patient safety by formation of toxic degradation products or deliver to lower dose than expected. Therefore it is to know the purity profile & behaviour of a drug substances under the various environmental condition. Forced Degradation studies show the chemical behavior of the molecule which in turn helps in the development of new formulation & package . Degradation study is required to the design of a regulatory compliant

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Ruksar, Rafique Parvin, Mohapatra Jagannath, Sahu Rubi, Panigrahi Debadash, and Mishra Amiyakanta. "Development and validation of a stability-indicating assay method for determination of metronidazole benzoate in bulk: Spectroscopic approach." GSC Biological and Pharmaceutical Sciences 24, no. 2 (2023): 040–50. https://doi.org/10.5281/zenodo.10369355.

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A new, simple, rapid, accurate, sensitive and cost effective spectrophotometric stability indicating assay method was developed for the quantification of metronidazole benzoate in bulk and validated according to ICH guidelines using different parameters. In the present study an attempted has been made to develop an effective method which will surpass the disadvantages associate with other reported methods like tedious in use, less sensitive and costly etc. The assay method was based on the forced degradation study of metronidazole benzoate under different ICH recommended stress conditions like

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Jaya, P. Ambhore, S. Adhao Vaibhav, S. Cheke Rameshwar, R. Popat Ritesh, and J. Gandhi Shital. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. https://doi.org/10.5281/zenodo.5168617.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa

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Bansal, Gulshan, Manjeet Singh, Kaur Chand Jindal, and Saranjit Singh. "Ultraviolet-Photodiode Array and High-Performance Liquid Chromatographic/Mass Spectrometric Studies on Forced Degradation Behavior of Glibenclamide and Development of a Validated Stability-Indicating Method." Journal of AOAC INTERNATIONAL 91, no. 4 (2008): 709–19. http://dx.doi.org/10.1093/jaoac/91.4.709.

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Abstract A forced degradation study on glibenclamide was performed under conditions of hydrolysis, oxidation, dry heat, and photolysis and a high-performance column liquid chromatographic-ultraviolet (HPLC-UV) method was developed to study degradation behavior of the drug under the forced conditions. The degradation products formed under different forced conditions were characterized through isolation and subsequent infrared/nuclear magnetic resonance/mass spectral analyses, or through HPLC/mass spectrometric (HPLC/MS) studies. The drug degraded in 0.1 M HCl and water at 85C toamajor degradati

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Zalewski, Przemysław, Judyta Cielecka-Piontek, and Anna Jelińska. "Development and validation of the stability-indicating LC-UV method for the determination of cefoselis sulphate." Open Chemistry 10, no. 1 (2012): 121–26. http://dx.doi.org/10.2478/s11532-011-0112-9.

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AbstractThe stability-indicating LC assay method was developed and validated for quantitative determination of cefoselis sulphate in the presence of degradation products formed during the forced degradation studies. An isocratic, RP-HPLC method was developed with C-18 (250 × 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (95:5 V/V) as a mobile phase. The flow rate of the mobile phase was 1.0 mL min−1. Detection wavelength was 260 nm and temperature was 30°C. Cefoselis similarly to other cephalosporins was subjected to stress conditions of degradation in aqueous solutions includin

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U. Shinde, Samadhan, Ruchita S. Bardiya, Pritam S. Jain, Atul A. Shikhedkar, and Akhil A. Nagar. "COMPARISON OF ACID DEGRADANT PRODUCT WITH METABOLIC PATHWAY OF REMOGLIFLOZIN ETABONATE IN DEVELOPED AND VALIDATED RP-HPTLC METHOD." Indian Drugs 59, no. 11 (2022): 46–53. http://dx.doi.org/10.53879/id.59.11.13183.

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Forced degradation studies in tablet and bulk formulations of remogliflozin etabonate have been developed using a precise and sensitive high performance thin layer chromatographic method. The silica gel RP-18 F254S plates were used as the stationary phase and ACN: water: ammonia solution (8:2:0.5 V/V/V) was used as the mobile phase for estimation. The proposed method was successfully validated, showing the Rf of the drug as 0.72 at 229 nm. The method was observed to be linear in the range of 500-3000 ng band-1 and then degradation was estimated by forced degradation pathway. In the forced degr

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Fernanda, M. A. Hanny Ferry, and Maulidia Ningsih. "Forced Degradation Study Of Paracetamol Levels Using Uv-Vis Spechtrophotometry." Journal Pharmasci (Journal of Pharmacy and Science) 8, no. 1 (2023): 15–20. http://dx.doi.org/10.53342/pharmasci.v8i1.312.

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Paracetamol or acetaminophen is a class of over-the-counter drugs widely used by the general public to treat fever and mild pain. The study aimed to determine the effect of forced degradation by hydrolysis on paracetamol levels using Uv-Vis Spectrophotometry. This type of research is experimental with the method used is Uv-Vis Spectrophotometry which is carried out at a wavelength of 200-400 nm. The results obtained from the study in the form of a linear regression equation y=0,0652x + 0,0269 with a value of R2 = 0,9938. Furthermore, paracetamol without degradation was 90,40%, while paracetamo

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Rugani, Karen de Souza, and Hérida Regina Nunes Salgado. "Stability-indicating LC method for the determination of cephalothin in lyophilized powder for injection." Anal. Methods 6, no. 12 (2014): 4437–45. http://dx.doi.org/10.1039/c3ay42049c.

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A stability-indicating gradient reversed phase liquid chromatography (RP-LC) method has been developed for the quantitative determination of cephalothin (CET), an antimicrobial compound, in the presence of its impurities and degradation products generated from forced degradation studies.

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Patel, Jitesha, Parin Chokshi, and Rajashree Mashru. "Validation of Stability Indicating Method and Degradation Kinetic Study of Apremilast." Journal of Drug Delivery and Therapeutics 10, no. 2 (2020): 76–85. http://dx.doi.org/10.22270/jddt.v10i2.3964.

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A novel stability indicating RP- HPLC method was developed for the estimation of Apremilast in bulk and marketed formulation. Separation was achieved by using Shimadzu HPLC Analytical Technologies Limited C18 (250 mm x 4.6 mm, 5µm) as stationary phase. The optimized mobile phase consist of potassium dihydrogen ortho phosphate (pH-3.2): acetonitrile in ratio of 40:60 %v/v with flow rate of 1mL/min by using methanol as diluent. Retention time of Apremilast was found to be 5.4 min which was estimated at wavelength 360nm. Linearity of Apremilast was observed in the concentration range of 50-400µg/

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Hadad, Ghada M., Randa A. Abdel Salam, and Eman A. Abdel Hamfeed. "Kinetics Investigation and Determination of Pipoxolan Hydrochloride and Its Degradant Using Liquid Chromatography." Journal of AOAC INTERNATIONAL 96, no. 4 (2013): 758–64. http://dx.doi.org/10.5740/jaoacint.10-519.

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Abstract An LC method was developed for the quantitative determination of pipoxolan hydrochloride (PPH) and its degradant. Forced degradation studies were performed on bulk sample using acid (1 M hydrochloric acid), alkaline (0.2 M sodium hydroxide), oxidation (0.33% hydrogen peroxide), heat (70°C), and photolytic degradation. The chromatographic method was fine-tuned using the samples generated from forced degradation studies. Good resolution between the peaks corresponding to the degradants and the analyte was achieved on a Discovery® C18 LC column (25 cm × 4.6 mm id, 5 μm particle size). Th

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Shivam, Jadhav* Sanket Deshmukh Shailesh Deshmukh Shivam Gayakwad Abhishek Nagre Shahebaz Deshmuk Dr. R. H. Kale. "Development And Validation of a Simple Stability Indicating High Performance Liquid Chromatographic Method for The Determination of Miconazole Nitrate in Bulk and Cream Formulations." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3239–48. https://doi.org/10.5281/zenodo.15464309.

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A simple, accurate, and stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of miconazole nitrate in both bulk drug and cream formulations. Chromatographic separation was achieved using a C18 column with a mobile phase comprising acetonitrile and phosphate buffer in an optimized ratio. The method demonstrated excellent linearity, precision, accuracy, and robustness in accordance with ICH guidelines. Forced degradation studies were performed under various stress conditions, including acidic, basic, oxidative, thermal, and

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D, Debaje Priyanka, and Chavan Harishchandra H. "Force Degradation Study of Tenofovir Disoproxil Fumarate by UV-Spectrophotometric Method." Asian Journal of Pharmaceutical Research and Development 8, no. 2 (2020): 21–25. http://dx.doi.org/10.22270/ajprd.v8i2.679.

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Tenofovir disoproxil Fumarate (TDF), acyclic phosphonate nucleotide analogue, used as antiretroviral agents in the treatment of HIV-1 infection. A stability indicating UV -spectrophotometric method is simple, an accurate and economic, precise and reproducible method has been used for the estimation of Tenofovir disoproxil Fumarate in bulk and tablets dosage form in present work. The wavelength selected for the absorption correction method was 260 nm. The linearity range of 2-10μg/ml proved that it obeyed Beer’s Law and the correlation coefficient (r2) was found to be 0.999 at 260 nm. The drug

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Kumar Sista, Venkata Sai Suresh, Anjali Jha, Vlnsh Hari Haran A, et al. "FORCED DEGRADATION AND STABILITY STUDY OF LENALIDOMIDE: IMPURITY PROFILING AND METHOD DEVELOPMENT USING HPLC." RASAYAN Journal of Chemistry 18, no. 03 (2025): 1482–87. https://doi.org/10.31788/rjc.2025.1839316.

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Lenalidomide is an immunomodulatory drug that plays a significant role in treating hematological conditions, including multiple myeloma and myelodysplastic syndromes. The stability of lenalidomide is crucial for maintaining its safety and effectiveness throughout its shelf life. Environmental factors such as light, heat, moisture, and changes in pH can lead to the degradation of lenalidomide, resulting in harmful impurities that may compromise its therapeutic potency. This research presents a novel approach to studying the stability of lenalidomide under various stress conditions using a High-

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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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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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Verma, Hitesh, Surajpal Verma, and Harmanpreet Singh. "A Stability Indicating Assay Method Development and Validation for the Frovatriptan Succinate Monohydrate by Using UV: A Spectrophotometric Technique." ISRN Spectroscopy 2013 (May 2, 2013): 1–6. http://dx.doi.org/10.1155/2013/361385.

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A new simple, reliable, inexpensive, and accurate method was developed for the quantification of Frovatriptan Succinate Monohydrate in different physiological media at 244 nm in bulk and in tablet dosage forms. The developed method is an attempt to surpass the disadvantages associated with the reported methods, namely, less sensitive and tedious in usage for routine purposes. Beer’s law was followed over the range of 1.0 µg/mL to 4.5 µg/mL. Stability indicating assay method was developed and validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit o

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Peterka, Tanja Rozman, Tina Trdan Lušin, Jure Bergles, Zoran Ham, Rok Grahek, and Uroš Urleb. "Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination." Acta Pharmaceutica 69, no. 3 (2019): 363–80. http://dx.doi.org/10.2478/acph-2019-0025.

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Abstract An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method was applied to analyses of commercial samples and was validated in terms of linearity, precision, accuracy, sensitivity and specificity. It was found to be linear, precise and accurate in the range of 0.05 to 0.6 % of the impurities level in pharmaceutical dosage forms. Stability indicatin

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Shyamala, ,. "DEVELOPMENT OF FORCED DEGRADATION STUDIES OF FAVIPIRAVIR BY RP-HPLC." Journal of Medical pharmaceutical and allied sciences 10, no. 6 (2021): 3823–26. http://dx.doi.org/10.22270/jmpas.v10i6.1493.

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Forced degradation studies and stability indicating method were developed for the estimation of Favipiravir by reverse phase High performance liquid chromatography in active Pharmaceutical ingredient and its tablet dosage form. The method was achieved by using C18 column (250 X 4.6mm X 4µm) with mobile phase mixture ortho phosphoric acid and acetonitrile in the ratio 60:40. The mobile phase was allowed to pump with the flow rate 1ml/min by maintaining detection wavelength at 324nm using ultra-violet detector. Favipiravir drug was subjected to various stress conditions according to Internationa

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Ruksar Rafique Parvin, Jagannath Mohapatra, Rubi Sahu, Debadash Panigrahi, and Amiyakanta Mishra. "Development and validation of a stability-indicating assay method for determination of metronidazole benzoate in bulk: Spectroscopic approach." GSC Biological and Pharmaceutical Sciences 24, no. 2 (2023): 040–50. http://dx.doi.org/10.30574/gscbps.2023.24.2.0293.

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A new, simple, rapid, accurate, sensitive and cost effective spectrophotometric stability indicating assay method was developed for the quantification of metronidazole benzoate in bulk and validated according to ICH guidelines using different parameters. In the present study an attempted has been made to develop an effective method which will surpass the disadvantages associate with other reported methods like tedious in use, less sensitive and costly etc. The assay method was based on the forced degradation study of metronidazole benzoate under different ICH recommended stress conditions like

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De Souza, Danielle Evangelista Rabelo, Nicoly Kaliny Magela Gomes, Gerson Antônio Pianetti, Bruno Gonçalves Pereira, and Christian Fernandes. "Rapid stability-indicating UHPLC method for determination of lamivudine and tenofovir disoproxil fumarate in fixed-dose combination tablets." Drug Analytical Research 5, no. 2 (2021): 17–24. http://dx.doi.org/10.22456/2527-2616.117905.

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Lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) are antiretroviral drugs widely used for AIDS treatment. Since safety, efficacy and quality are essential for drug products, stability studies must be performed. Therefore, degradation studies must be carried out to evaluate the degradation products formed. The active pharmaceutical ingredients 3TC and TDF, as well as the tablets containing the combination of these drugs were subjected to a comprehensive forced degradation. 3TC, TDF and the degradation products were analyzed by a stability-indicating ultra-high performance liquid chromat

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Runje, Mislav, Sandra Babić, Ernest Meštrović, Irena Nekola, Željka Dujmić-Vučinić, and Nina Vojčić. "Forced degradation of nepafenac: Development and validation of stability indicating UHPLC method." Journal of Pharmaceutical and Biomedical Analysis 123 (May 2016): 42–52. http://dx.doi.org/10.1016/j.jpba.2016.02.003.

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NIKAM, Kanchan, Sachin BHUSARI, and Pravin WAKTE. "High Performance Liquid Chromatography Method Validation and Forced Degradation Studies of Chrysin." Journal of Research in Pharmacy 27(1), no. 27(1) (2023): 264–73. http://dx.doi.org/10.29228/jrp.309.

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Patil, Raj, and Rahul Keshav Godge. "Validated Stability Indicating UHPLC Method for the Quantification of Escitalopram and Flupentixol in Pharmaceutical Formulation." International Journal of Experimental Research and Review 38 (April 30, 2024): 37–45. http://dx.doi.org/10.52756/ijerr.2024.v38.004.

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To assess Escitalopram and flupentixol simultaneously, a verified method for ultra-phase high-performance liquid chromatography (UHPLC) has been developed to indicate stability. The method was thoroughly evaluated and met satisfactory criteria for precision, linearity, accuracy, limits on detection, robustness, and quantitation. The quantitation wavelength of 235 nm was determined. Linearity was successfully demonstrated across concentration ranges of 1–5 µg/ml of Escitalopram and 20-100 µg/ml of Flupentixol. UHPLC separations were conducted employing a Phenomenex L. C18 column measuring 100 x

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Jaya P. Ambhore, Vaibhav S. Adhao, Rameshwar S. Cheke, Rameshwar S. Cheke, Ritesh R. Popat, and Shital J. Gandhi. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. http://dx.doi.org/10.30574/gscbps.2021.16.1.0172.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summa

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Azeez, Rashid, Masood Ahmed Siddiqui, and Ziyaurrahman Azeez. "A Novel Validated High Performance liquid chromatographic stability indicating assay method for the chemical analytical quantification of Norethindrone Tablets and their degradation study." Der Pharma Chemica 13, no. 5 (2021): 13. https://doi.org/10.5281/zenodo.11072352.

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Norethindrone is a synthetic chemical analogue of naturally occurring steroid whose structure is chemically based on a steroid nucleus-a hydrogenated cyclopentanoperhydrophenanthrene ring having 17 carbon atoms. This is new drug and vital in medicine. Tablet dosage form is new pharmaceutical formulation and used as oral contraceptive. They are low dose and have less label claim. The development and validation of assay method by RP-HPLC-DAD is challenging and not yet reported. The objective of this research was to develop and validate a precise, efficient, specific, accurate and stability indic

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