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Journal articles on the topic 'Forced Degradation Stability studies'

Author: Grafiati

Published: 3 June 2025

Last updated: 1 August 2025

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1

Sonawane, Jayshree Kishor, Siddhi Maruti Chavan, Ishwari Prakash Narkar, et al. "A Review of Stability Indicating Methods and Forced Degradation Studies." International Journal of Research Publication and Reviews 4, no. 5 (2023): 4703–15. http://dx.doi.org/10.55248/gengpi.4.523.42372.

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Sutar, Shubhangi V., Veerendra C. Yeligar, and Shitalkumar S. Patil. "Stability Indicating Forced Degradation Studies." Research Journal of Pharmacy and Technology 12, no. 1 (2019): 429. http://dx.doi.org/10.5958/0974-360x.2019.00078.7.

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Sutar, Shubhangi V., Veerendra C. Yeligar, and Shitalkumar S. Patil. "A Review: Stability Indicating Forced Degradation Studies." Research Journal of Pharmacy and Technology 12, no. 2 (2019): 885. http://dx.doi.org/10.5958/0974-360x.2019.00152.5.

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John, Christina V., and Aruna P. Jadhav. "FORCED DEGRADATION STUDIES OF VINCAMINE BY HPTLC." INDIAN DRUGS 60, no. 11 (2023): 59–62. http://dx.doi.org/10.53879/id.60.11.14129.

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Vincamine is an alkaloid with vasodilator properties. Vinpocetine, a semi-synthetic vincamine derivative alkaloid, is used to treat cerebrovascular diseases like stroke and dementia. Being an important molecule, the current research work examines the forced degradation studies of vincamine using planar chromatography, HPTLC using stability studies parameters such as degradation by acid and base hydrolysis, oxidative stress degradation, hydrolytic induced degradation, photolytic degradation and dry heat degradation. The compound was found to be stable to oxidative stress, but significant degrad

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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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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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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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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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Yulianita, Rini, Iyan Sopyan, and Muchtaridi Muchtaridi. "FORCED DEGRADATION STUDY OF STATINS: A REVIEW." International Journal of Applied Pharmaceutics 10, no. 6 (2018): 38. http://dx.doi.org/10.22159/ijap.2018v10i6.29086.

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Forced degradation study is the degradation of new drug substances and drug products in more severe conditions than accelerated conditions. Forced degradation study were conducted to demonstrate the specificity of stability-indicating methods, providing insight into degradation pathways and drug degradation products, assisting in the elucidation of degradation product structures, identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability st

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10

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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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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R.Jadhav, Pralhad, Yogesh Sonawane, and Ganesh Sonawane. "Impact of Forced Degradation Studies on the Formulation and Stability of Topiroxostat: A Comprehensive Review." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 85–93. https://doi.org/10.35629/4494-10028593.

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Topiroxostat, a selective xanthine oxidase inhibitor used in the treatment of gout and hyperuricemia, plays a critical role in regulating purine metabolism by reducing serum urate levels. However, especially when developing formulations, its stability is essential to preserve the therapeutic efficacy. In order understand Topiroxostat degradation routes and ensure its stability in pharmaceutical formulations, forced degradation studies are important. By purposefully simulating extreme conditions, these experiments aid in the identification of degradation products and mechanisms, including oxida

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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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K. Poonkuzhali, Nagi Pravalika, Nakka Kaveri, Nalukapally Uday Kiran, Narimalla Ankitha, and Nayakini Sravani. "Forced Degradation Studies on Anti-Cancer Drugs: A Comprehensive Review." IJPAR JOURNAL 14, no. 1 (2025): 1–7. https://doi.org/10.61096/ijpar.v14.iss1.2025.1-7.

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Forced degradation studies are essential to understanding the stability, safety, and efficacy of anti-cancer drugs, playing a critical role in ensuring their reliability throughout the product lifecycle. These studies expose pharmaceutical compounds to controlled stress conditions—such as heat, light, oxidation, and hydrolysis—to simulate long-term storage and identify degradation pathways. Anti-cancer drugs, due to their intricate molecular structures and sensitivity, are particularly prone to degradation, making these studies indispensable in pharmaceutical development and regulatory complia

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Khan, Zarwali, Maria Yaseen, Ihsan Ali, et al. "Forced Degradation and Stability Indicating Studies for Clomifene Citrate Tablet." Asian Journal of Chemical Sciences 14, no. 1 (2023): 28–44. http://dx.doi.org/10.9734/ajocs/2023/v14i1251.

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Pharmaceutical medications must be stable to preserve their efficacy and safety over the period of their shelf lives. Studies on force degradation are crucial for identifying probable degradation pathways and identifying extreme stresses that may lead to the breakdown of the pharmaceutical product. This report offers a thorough analysis of the force degradation tests performed on Clomifene citrate tablets. Evaluation of the effects of several stress factors, including temperature, humidity, light, and mechanical forces, on the stability of clomifene citrate is the main goal. To replicate actua

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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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Darugu, Chowdeswari Darugu, B. Prasada Rao, Ch S. Anuradha, J. Santosh Kumar, and S. Shobha Rani. "Forced Degradation Studies for Glycopyrrolate, Formoterol & Budesonide By UPLC." International Journal of Membrane Science and Technology 10, no. 5 (2023): 860–66. http://dx.doi.org/10.15379/ijmst.v10i5.3579.

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Forced degradation studies include the degradation of new drug substance and drug product at conditions more severe than accelerated conditions. These studies illustrate the chemical stability of the molecule which further facilitates the development of stable formulation with suitable storage conditions. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc.

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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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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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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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Modi, J. G., J. K. Patel, N. A. Gohel, K. G. Modi, and K. S. Patel. "SIGNIFICANCE OF FORCED DEGRADATION STUDIES FOR DRUG SUBSTANCE AND DRUG PRODUCTS WITH REFERENCE TO ANTIHYPERTENSIVE AGENTS." INDIAN DRUGS 53, no. 01 (2016): 5–17. http://dx.doi.org/10.53879/id.53.01.10467.

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Stability testing is used to provide evidence of how the quality of an Active Pharmaceutical Ingredient (API) or drug product varies with time under the infuence of a variety of environmental factors such as temperature, humidity and light. If drug product is not stable under various environmental conditions, it may affect the patient safety by formation of a toxic degradation product(s) or deliver a lower dose than expected. Stress testing of the API can help to identify the likely degradation products, which, in turn, can help to establish the degradation pathways and the intrinsic stability

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Agrawal, Sneha, Sagarika Dhamne, and Pradum Shinde. "FORCE DEGRADATION AND STABILITY STUDY OF 7-HYDROXY COUMARIN." INDIAN DRUGS 61, no. 06 (2024): 70–73. http://dx.doi.org/10.53879/id.61.06.14505.

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The research investigates the stability of 7-hydroxy coumarin i.e. umbelliferone, a compound with diverse applications, through forced degradation studies under various conditions. These investigations aim to comprehend its susceptibility to degradation and provide insights crucial for its safe handling and formulation. Umbelliferone displays differing degrees of vulnerability to distinct stressors: it exhibits higher susceptibility to alkali-induced and photolytic degradation, signaling the necessity for cautious management under these conditions. Conversely, it demonstrates moderate suscepti

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Singh, Saranjit, Mahendra Junwal, Gajanan Modhe, et al. "Forced degradation studies to assess the stability of drugs and products." TrAC Trends in Analytical Chemistry 49 (September 2013): 71–88. http://dx.doi.org/10.1016/j.trac.2013.05.006.

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Savic, Ivan, Goran Nikolic, Ivana Savic, and Milorad Cakic. "Conductometric studies on the stability of copper complexes with different oligosaccharides." Open Chemistry 8, no. 5 (2010): 1078–85. http://dx.doi.org/10.2478/s11532-010-0082-3.

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AbstractBioactive copper complexes with pullulan or dextran oligosaccharides are the subject of intensive research mainly because of their possible application in veterinary and human medicine. The thermal stability and stability under oxidative conditions of the Cu(II) complexes with reduced low-molar pullulan or dextran were investigated in this paper, using a conductometric method. The influence of ligand constitutions on the stability of the complexes was examined on the basis of ligand property. Forced degradation studies were performed on bulk sample of complexes by using heat (25, 40 an

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Roberto de Alvarenga Junior, Benedito, and Renato Lajarim Carneiro. "Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs." Molecules 24, no. 20 (2019): 3804. http://dx.doi.org/10.3390/molecules24203804.

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Chemometrics is the chemistry field responsible for planning and extracting the maximum of information of experiments from chemical data using mathematical tools (linear algebra, statistics, and so on). Active pharmaceutical ingredients (APIs) can form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity, and oxidative environment. By considering that these impurities can affect the safety and efficacy of the drug product, it is necessary to know how these impurities are yielded and to establish the pathway of t

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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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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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Talati, A. S., and H. N. Dave. "FORCED DEGRADATION STUDIES AND ASSESSMENT OF DEGRADATION PRODUCTS OF IMEGLIMIN HYDROCHLORIDE USING LC-ESI/APCI-MS." RASAYAN Journal of Chemistry 17, no. 04 (2024): 1903–9. http://dx.doi.org/10.31788/rjc.2024.1749002.

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Forced degradation subjects drug substances to stress conditions, producing degradation products that are crucial for evaluating stability under accelerated conditions. Imeglimin hydrochloride is a commonly prescribed medicine for managing type 2 diabetes mellitus. This study details the forced degradation experiments and LC-MS analysis of degraded products of Imeglimin Hydrochloride under various stress conditions, offering insights into its stability and providing information on fragmentation pathways and major degradation products. The optimized mobile phase for the LC-MS method was compose

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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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Blessy, M., Ruchi D. Patel, Prajesh N. Prajapati, and Y. K. Agrawal. "Development of forced degradation and stability indicating studies of drugs—A review." Journal of Pharmaceutical Analysis 4, no. 3 (2014): 159–65. http://dx.doi.org/10.1016/j.jpha.2013.09.003.

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Chandramore, Kavita, and Sandeep Sonawane. "Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods." Biosciences Biotechnology Research Asia 19, no. 4 (2022): 881–94. http://dx.doi.org/10.13005/bbra/3039.

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ABSTRACT: This article provides an overview on Development and Validation of Force degradation study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions (hydrolysis, oxidation, thermal, and photolytic conditions) are applied to drugs compounds during a process known as forced degradation, and as a result, various degradation products are created. The major purpose of these investigations is to assess a molecule's stability under accelerated settings. It is well recognized that the stability of molecules affects the regulatory documentation process, the cho

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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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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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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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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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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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Cristina, Laignier Cazedey Edith, Sanjay Garg, and Nunes Salgado Herida Regina. "Evaluation and Degradation Chemistry of Orbifloxacin using LC-MS." International Journal of Sciences Volume 2, no. 2013-09 (2013): 11–20. https://doi.org/10.5281/zenodo.3348434.

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Orbifloxacin (ORBI) was subjected to different ICH (Q1A(R2)) prescribed stress conditions of thermal stress, hydrolysis, oxidation and photolysis. It was stable to dry heat (60 ºC) and photolysis (UV-VIS) in solid form. It showed extensive decomposition under hydrolytic and photolytic conditions in acid, base and neutral solutions. Degradation was also observed in oxidative condition. Degradation products of ORBI formed under different forced conditions were characterized through LC–MS studies. In total, eleven major degradation products (DP1-DP11) were detected. Successful separation of drug

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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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Yilmaz, Hulya, and Mustafa Culha. "A Drug Stability Study Using Surface-Enhanced Raman Scattering on Silver Nanoparticles." Applied Sciences 12, no. 4 (2022): 1807. http://dx.doi.org/10.3390/app12041807.

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Pharmaceutical product quality is of vital importance for patient safety. Impurities and potential degradation products can cause changes in chemistry, pharmacological and toxicological properties by having a significant impact on product quality and safety. Stress-testing (forced degradation) studies of pharmaceutical preparations became necessary to assure degradation mechanisms and potential degradation products. Consequently, it is crucial to understand the nature of possible degradation products. Surface-enhanced Raman spectroscopy (SERS) is a powerful vibrational spectroscopic technique

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Secretan, Philippe-Henri, Maxime Annereau, Willy Kini-Matondo, et al. "Unequal Behaviour between Hydrolysable Functions of Nirmatrelvir under Stress Conditions: Structural and Theoretical Approaches in Support of Preformulation Studies." Pharmaceutics 14, no. 8 (2022): 1720. http://dx.doi.org/10.3390/pharmaceutics14081720.

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Nirmatrelvir is an antiviral drug approved for the treatment of COVID-19. The available dosage form consists of tablets marketed under the brand name PAXLOVID®. Although knowledge of nirmatrelvir’s intrinsic stability may be useful for any potential development of other pharmaceutical forms, no data regarding this matter is available to date. Preliminary forced degradation studies have shown that the molecule is stable under oxidative and photolytic conditions, while hydrolytic conditions, both acidic and basic, have proven deleterious. Indeed, the molecule presents a priori several functions

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Mascarello Junior, Idamir José, Rafaela Martins Sponchiado, Leticia Malgarin Cordenonsi, Tércio Oppe Oppe, and Elfrides Eva Scherman Shapoval. "Ceftaroline fosamil: development a rapid HPLC method indicating stability and bioassay for determination in pharmaceutical formulation, stability and cytotoxicity studies." Drug Analytical Research 5, no. 2 (2021): 36–44. http://dx.doi.org/10.22456/2527-2616.120343.

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The present study reports the development and validation of a microbiological assay. To assess this methodology, the method was developed and validated for the quantification of CEF by high performance liquid chromatography (HPLC). The validation of the microbial assay by diffusion method in 3x3 cylinder agar presented showed satisfactory results as to specificity, linearity in the range of 2.0 - 8.0 μg.mL-1, precision (109.42 %), accuracy (102.3 %), and robustness. The development and validation of the method by HPLC were evaluated according to specificity, linearity, precision, accuracy and

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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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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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Hasan, Md Sharif, Ruhul Kayesh, Farida Begum, and S. M. Abdur Rahman. "Transition Metal Complexes of Naproxen: Synthesis, Characterization, Forced Degradation Studies, and Analytical Method Verification." Journal of Analytical Methods in Chemistry 2016 (2016): 1–10. http://dx.doi.org/10.1155/2016/3560695.

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The aim of our current research was to synthesize some transition metal complexes of Naproxen, determine their physical properties, and examine their relative stability under various conditions. Characterizations of these complexes were done by 1H-NMR, Differential Scanning Calorimetry (DSC), FT-IR, HPLC, and scanning electron microscope (SEM). Complexes were subjected to acidic, basic, and aqueous hydrolysis as well as oxidation, reduction, and thermal degradation. Also the reversed phase high-performance liquid chromatography (RP-HPLC) method of Naproxen outlined in USP was verified for the

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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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Rathor, Shahbaz, and Atul Sherje. "FORCED DEGRADATION STUDIES OF TIZANIDINE HYDROCHLORIDE AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING RP-HPLC METHOD." INDIAN DRUGS 58, no. 4 (2021): 50–55. http://dx.doi.org/10.53879/id.58.04.11226.

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Simple and precise stability indicating RP-HPLC method for the quantitative determination of tizanidinehydrochloride (TZN) in pharmaceutical dosage form was developed and validated. The separation was achieved using Atlantis C18 column (250 x 4.6 mm, 5µm) at 25 °C using a mobile phase containing 20mM KH2 PO4 (pH 3.5):methanol in the ratio of 30:70 V/V at 0.8 mL/min flow rate and 315nm detection wavelength. The retention time for TZN was 3.7 min and showed linearity in the 5-40µg/mL range with R2 >0.99. The drug was subjected to acid/ base hydrolysis, oxidative and thermal degradation to est

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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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Salman, D., J. M. R. Peron, T. Goronga, S. Barton, J. Swinden, and S. Nabhani-Gebara. "HPLC & NMR-based forced degradation studies of ifosfamide: The potential of NMR in stability studies." Annales Pharmaceutiques Françaises 74, no. 2 (2016): 119–28. http://dx.doi.org/10.1016/j.pharma.2015.09.004.

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Parys, Wioletta, Małgorzata Dołowy, and Alina Pyka-Pająk. "Rapid TLC with Densitometry for Evaluation of Naproxen Stability." Processes 8, no. 8 (2020): 962. http://dx.doi.org/10.3390/pr8080962.

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The purpose of the work was to develop such chromatographic conditions that allowed to separate as many naproxen degradation products as possible. In order to follow this process, thin-layer chromatography (TLC) coupled with densitometry and spectrodensitometry was used. A forced degradation study was performed using an ethanolic solution of naproxen spotted on silica gel plates, existing in the form of an aqueous solution at various pH values, and as solution prepared in saline and in hydrogen peroxide. Degradative effect of UV light on naproxen was watched in the context of naproxen spotted

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D., Titus a. *. Dr. K. Srinivas Reddy b. SK. Nasreen c. Dr. D. Kumara Swamy d. CH. Sumanth c. Dr. K. Praveen Kumar e. "RP-HPLC METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES FOR THE ESTIMATION OF AMITRIPTYLINE HYDROCHLORIDE AND PERPHENAZINE IN BULK." Journal of Pharma Research 8, no. 1 (2019): 34–40. https://doi.org/10.5281/zenodo.2555311.

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<strong><em>ABSTRACT</em></strong> <strong><em>A</em></strong><em> new, simple, precise, accurate and reproducible RP-HPLC method was validated for the estimation of Amitriptyline Hydrochloride (AMT) and Perphenazine (PRP) & Stability indicating Studies were performed. Separation of Amitriptyline Hydrochloride and Perphenazine was successfully achieved on Hypersil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol:Water (90:10) at a flow rate of 1.0 ml/min and eluents were monitored at 247 nm with a retention time of 4.235 and 3.490 minutes for and Amitriptyline Hydro

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