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Journal articles on the topic 'ICH Guidelines Impurity profiling'

Author: Grafiati

Published: 3 June 2025

Last updated: 1 August 2025

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1

Yash, B. Pokiya *1 Vaishali V. Karkhanis2. "Impurity Profiling of Anti-Malarial Drugs." International Journal in Pharmaceutical Sciences 2, no. 8 (2024): 3963–89. https://doi.org/10.5281/zenodo.13619629.

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Impurities are the unwanted materials which can interact with the pharmaceutical product and affects the quality of the product or the formulation. According to ICH guidelines, impurity is the part of the drug substance which affects the quality and purity of the active ingredients. Therefore, its identification and control is the major issue in the formulation industries. For the control and the limits of the impurity in the pharmaceutical dosage form, International Conference on Harmonization (ICH) formulated the guidelines for the impurity control and management. In this review, list of the

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Mansi, Rana*1 Vikram Pandya2. "Overview On Impurity Profiling For Pharmaceutical Drug Candidates." International Journal in Pharmaceutical Sciences 2, no. 4 (2024): 586–93. https://doi.org/10.5281/zenodo.10955539.

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Impurity profiling plays a crucial role in the pharmaceutical industry to ensure the safety, efficacy, and quality of drug products. This review provides an overview of impurity profiling methodologies, focusing on pharmaceutical drug candidates. It begins with an introduction to impurities, including their classification and sources. Moreover, the importance of impurity thresholds and regulatory guidelines established by organizations like the International Council for Harmonisation (ICH) and the United States Pharmacopeia (USP) is highlighted. Furthermore, strategies for impurity control dur

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Gogna, Kunal. "Regulatory aspects of Impurity profiling." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 45–54. http://dx.doi.org/10.22270/ijdra.v8i4.433.

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Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines o

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B, Bhagwat Ashlesha, and Khedkar K. M. "Impurity Profiling: A Review." Asian Journal of Pharmaceutical Research and Development 10, no. 2 (2022): 135–43. http://dx.doi.org/10.22270/ajprd.v10i2.1052.

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Impurities are any substances, such as starting materials or intermediates, that coexist with the parent drug or arise from side reactions. Interest in impurities present in APIs continues to grow. Nowadays, not only purity profile but also impurity profile is mandated by various regulatory agencies. Impurity profiling is a generic name for a group of analytical working groups such as describing, quantifying and characterizing identified and unidentified impurities present in a new drug substance. Impurity profiling is a novel approach aimed at detecting, identifying, structuring and quantifyi

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Swati, Dubey Ravindra Kumar Pandey Shiv Shankar Shukla*. "IMPURITY PROFILING AND DRUG CHARACTERIZATION: BACKDROP AND APPROACH." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2499–515. https://doi.org/10.5281/zenodo.1218717.

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Impurities are always an ‘essential evil’, that will however be present with the drug products with but with the dawn of more safety based limits for controlling the related impure substances (ICH Q3A-D and M7) it can be relied that such controlling authorities will better comprehend the course of action and consent to an appropriate tolerable limits to possibility (commercial and patient needs).Impurity produced either through formulation or in the lead ageing of both API’s and formulated products in medicines. These unwanted chemicals, present even in small amount, may infl

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Phuge, Ashish, Rekha Bhalerao, and Vijaya Barge. "A Review On Chromatographic Method Development And Impurity Profiling." PDEAS International Journal of Research in Ayurved and Allied Sciences 1, no. 1 (2019): 28–32. https://doi.org/10.63778/pdeasijraas-arjcpl/2019_21530.

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Stability indicating assay method (SIAM) is a validated quantitative analytical procedure that can detect changes with time in the properties of the drug substance and drug product under defined storage conditions. It accurately measures the API without interference from other substances and is sensitive enough to detect and quantify even small amounts of degradation products/impurities. To develop a SIAM, stress testing in the form of forced degradation should be carried out as per International Conference On Harmonization (ICH) Guidelines at an early stage so that impurities and degradation

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Orlandini, Serena, Gabriel Hancu, Zoltán-István Szabó, et al. "New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods." Molecules 27, no. 20 (2022): 7058. http://dx.doi.org/10.3390/molecules27207058.

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Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices. The adoption of Quality by Design (QbD) concepts in analytical method development, optimization and validation is a widespread trend observed in various analytical approaches including chiral CE. The application of Analytical QbD (AQbD) leads to the development of analytical methods based on sound science combined with risk management, and to a well understood process clarifying the influence of met

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Bhole, R. P., S. R. Jagtap, C. G. Bonde, and Y. B. Zambare. "Development and validation of stability indicating HPTLC method for estimation of pirfenidone and characterization of degradation product by using mass spectroscopy." Bulletin of the Karaganda University. "Chemistry" series 99, no. 3 (2020): 51–60. http://dx.doi.org/10.31489/2020ch3/51-60.

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Pirfenidone is used as a novel antifibrotic agent approved for mild-to-moderate idiopathic pulmonary fibrosis. An extensive literature search revealed that, method validation by high-performance thin-layer chromatography (HPTLC) and structural determination by tandem mass spectrometry (MS/MS) method was not reported till date. Precoated silica gels plates were used as a stationary phase. Methanol: ethyl acetate: toluene (1:2:7 v/v) was delivered best separation at 315 nm (Rf 0.49±0.03) by densitometry analysis. Degradation analysis was performed as per ICH guidelines Q2 (R1). Isolation of degr

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Peddi, Pavani, P. T. S. R. K. Prasada Rao, Chebolu Naga Sesha Sai Pavan Kumar, Nannapaneni Usha Rani, and S. Lakshmi Tulasi. "Impurity Profiling and a Stability Indicating Advanced Liquid Chromatographic Method Development and Validation for the Estimation of Related Impurities of Anagrelide." Asian Journal of Chemistry 36, no. 2 (2024): 325–30. http://dx.doi.org/10.14233/ajchem.2024.30785.

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A novel, streamlined and highly selective isocratic liquid chromatographic method has been developed for the quantification of impurities present in anagrelide. Exceptional resolution between anagrelide and its impurities was accomplished utilizing a Waters Nova Pack C18 column (250 mm × 4.6 mm, 4 µm), employing a phosphate buffer with a pH of 4.4 as mobile phase A and a blend of acetonitrile and methanol with buffer in a 30:40:30 v/v/v ratio as mobile phase B. The column oven was maintained at 35 ºC and the mobile phase flowed at a constant rate of 1.0 mL/min, while detection was set at 254 n

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Maganti, Sivaji, Suryakala Duvvuri, Srivathsa Degekar Gouni, Pavani Kadupu, and M. Bhaskara Praveen Varma. "RP-HPLC Method for the Quantification of Impurities in Etelcalcetide Injection and a Comparative Characterization Study of In-House Samples of Etelcalcetide Injection with Reference-Listed Drug Samples." Asian Journal of Chemistry 37, no. 4 (2025): 968–74. https://doi.org/10.14233/ajchem.2025.33486.

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In present study, an accurate and simple reversed phase-high performance liquid chromatography (RP-HPLC) method for the determination of potential impurities resulting from etelcalcetide injection was validated. An Ace Excel 3 C18 amide column with 100% 0.1 M sodium perchlorate (pH 2.0) buffer (100%) was used as mobile phase A and a 60:10 (%v/v) ratio of acetonitrile and 0.1 M sodium perchlorate (pH 2.0) was used as mobile phase B. The wavelength detection performed at 210 nm. Etelcalcetide injection was subjected to thermal, photolytic, acid, base, and peroxide degradation conditions, which w

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Ibrahim, Adel Ehab, Sami El Deeb, Emad Mahmoud Abdelhalim, Ahmed Al-Harrasi, and Rania Adel Sayed. "Green Stability Indicating Organic Solvent-Free HPLC Determination of Remdesivir in Substances and Pharmaceutical Dosage Forms." Separations 8, no. 12 (2021): 243. http://dx.doi.org/10.3390/separations8120243.

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A green liquid chromatographic method is considered in this work to minimize the environmental impact of waste solvents. One important principle is to replace or eliminate the use of hazardous organic solvents. Organic impurities in any active pharmaceutical ingredient could arise either during the process of its synthesis, or as degradation products developed throughout the shelf-life. Remdesivir (RDS) is an antiviral drug, approved by the US Food and Drug Adminstration (-FDA), to treat SARS-Cov-2 virus during its pandemic crisis. We studied the stability of remdesivir against several degrada

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Prajapati, Pintu B., Navneet Wankhed, and Priti J. Mehta. "A Review on Multi Approaches for Impurity Isolation and its Characterization." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 793–802. http://dx.doi.org/10.22270/jddt.v9i4-a.3627.

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International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review, the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other regulatory bodies and drug development authorities look up to these guidelines for launching a quality

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Rajnanda, Patil* Srushti Aoundhkar Priyanka Mohite Dr. D. R. Jadge. "Impurity profiling of pharmaceutical Formulation." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4520–27. https://doi.org/10.5281/zenodo.15524774.

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Impurity profiling is an essential tool for the pharmaceutical business, and this article delves into that role extensively. Drug safety and effectiveness might be jeopardized when active pharmaceutical ingredients (APIs) are mixed with impurities, which are undesirable chemical compounds. To guarantee the detection and control of contaminants in both APIs and formulated goods, numerous regulatory agencies have set rigorous purity standards, such as ICH, FDA, and CDHA. Particular emphasis is placed on the limits that can be tolerated for organic, inorganic, and residual solvent contaminants. T

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Nath, Dipankar, and Bidhya Sharma. "Impurity Profiling-A Significant Approach in Pharmaceuticals." Current Pharmaceutical Analysis 15, no. 7 (2019): 669–80. http://dx.doi.org/10.2174/1573412914666181024150632.

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There has been ever increasing interest in impurities present in Active Pharmaceutical Ingredient’s (API’s). Nowadays, not only purity profile but also impurity profile has become mandatory according to the various regulatory authorities. In the pharmaceutical world, an impurity is considered as an inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arising out of synthesis or unwanted chemicals that remains with APIs. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation pr

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

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

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Shounak R. Mande, Shankar S. Yelmame, and Laxmikant B. Borse Laxmikant B. Borse. "A Review on Impurity Profiling In Pharmaceutical Substances." Asian Journal of Pharmaceutical Research and Development 12, no. 5 (2024): 46–51. http://dx.doi.org/10.22270/ajprd.v12i5.1477.

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The term "impurity profiling" describes a group of analytical techniques aimed at detecting, identifying, and quantifying residual solvents and organic and inorganic impurities in bulk medications and pharmaceutical formulations. This is the main objective of contemporary drug analysis since it is the most effective method of characterizing the stability and quality of pharmaceutical formulations and bulk drugs. To monitor them, certain analytical methods have to be developed. Even in cases where synthesis, formulation, or production procedures are improved, new purities may emerge from change

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Prof., D. Gowri Sankar* P. Akhila N. Arun Kumar D. S. V. S. Prasad M. N. L. Renuka S. Rupa Lavanya. "SCOPE OF IMPURITY PROFILING IN PHARMACEUTICAL INDUSTRY AND FOCUS ON IMPURITIES THAT MAY OCCUR IN ANTICANCER DRUGS (VINBLASTINE AND PACLITAXEL)." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 02 (2018): 1316–21. https://doi.org/10.5281/zenodo.1204728.

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Now a day’s qualification of impurities has become a major task for pharmaceutical industry in order to maintain its biological safety. According to various regulatory authorities like ICH, USFDA, and Canadian drugs and health agency, along with purity profile, the impurity profile of drug has gained utmost importance in order to prove that the formulation is safe and efficient throughout its shelf life. Impurities may be developed during any stage of formulation that is from procurement of raw material to the marketing of the finished products. They may also occur during the storage of

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Nishanth G, Akhila G, Anandkumar Tengli, et al. "Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling." International Journal of Research in Pharmaceutical Sciences 11, no. 3 (2020): 2909–21. http://dx.doi.org/10.26452/ijrps.v11i3.2375.

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Impurity profiling is known to identify, classify and measure both the identified and non-identified contamination present on the medicinal product. Unwanted chemicals which remain or are created during the formulation of medicinal products are pharmaceutical impurities. Impurity profiling helps in the detection, recognition and quantification in bulk products and pharmaceutical formulations of various types of impurities, as well as residual solvents. It is the simplest way to distinguish consistency and stability of bulk drugs and medication formulations. As analytical methodology has develo

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Vimla, Soni. "Analytical Method Development and Validation Method for The Estimation of Related Impurities in Combined Dosage Form of Atazanavir and Cobicistat By RP-HPLC." International Journal of Pharmacy and Biological Sciences (IJPBS) 13, no. 3 (2023): 179–90. https://doi.org/10.5281/zenodo.10417546.

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AbstractA simple, economic, selective, and precise RP-HPLC method has been developed and validated for the estimation of related impurities of Atazanavir and Cobicistat in combined dosage form. Chromatographic separation has been achieved by using LC-20 AT C18 (250mm x 4.6mm, 5μm) column and using mobile phase buffer (potassium dihydrogen phosphate, pH 3.0): acetonitrile (60:40), 1mL/min was a flow rate. Samples were scanned at a wavelength of 224 nm. As per the ICH guidelines the method is validated. Retention time of Cobicistat and Atazanavir were found to be 5.247 and 3.513 respectively

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Burle, Gowri Sankararao, Praneeth Rao Kakullamarri, Suresh Babu Kothamasu, Sudha Divya Madhuri Kallam, and Anoop Bodapati. "Case Study on Regulatory Approaches for New Degradation Impurity Exceeding ICH Thresholds in Solubilized Ibuprofen Capsules During Stability Testing." Journal of International Research in Medical and Pharmaceutical Sciences 19, no. 3 (2024): 70–82. http://dx.doi.org/10.56557/jirmeps/2024/v19i38936.

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The article discusses the identification, isolation, characterization, and toxicology study of a new degradation impurity found in stability samples of Ibuprofen soft gelatin capsules. An unknown impurity was detected during stability analysis, reaching 0.28% level, which prompted further investigation. A preparative method was developed to isolate the impurity quickly, followed by its identification and characterization using spectroscopic techniques. The impurity, named 2,3-dihydroxxypropyl 2-(4-isobutylphenyl)propanoate, was confirmed through various analyses, including HPLC, LC-MS, NMR, an

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Rajana, Nagaraju, Dharamasoth Rama Devi, Dinne Naresh Kumar Reddy, J. Moses Babu, K. Basavaiah, and K. Balakumaran. "Characterization of Five Oxidative Degradation Impurities and One Process Impurity of Suvorexant Drug Substance by LC-MS/MS, HR-MS and 1D, 2D NMR: Validation of Suvorexant Drug Substance and Process Impurities by HPLC and UPLC." Journal of Chromatographic Science 58, no. 5 (2020): 433–44. http://dx.doi.org/10.1093/chromsci/bmaa003.

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Abstract During the oxidative (10% H2O2) degradation of suvorexant drug substance, around 1.0% of one impurity and less than 1.0% four impurities were found by a new high-performance liquid chromatography (HPLC) assay and related substance method. The mass numbers of 1.0% impurity was 469 [M + H]+, remaining four impurities were 172 [M + H]+, 467 [M + H]+, 483 [M + H]+ and 485 [M + H]+. The 469 [M + H]+, 485[M + H] and 172 [M + H]+ impurities were characterized by using the LC-MS/MS, HR-MS and 1D, 2D NMR spectroscopic data. The 172 [M + H]+ impurity was prepared synthetically and co-injected i

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M. Tathe, Reshma, Vrushali S. Tambe, Archana M. Karnik, and Santaji U. Nalwade. "NOVEL STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF CLOBAZAM AND ITS RELATED SUBSTANCES IN ORAL SUSPENSION." Indian Drugs 59, no. 11 (2022): 65–72. http://dx.doi.org/10.53879/id.59.11.12709.

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A novel, sensitive, stability-indicating gradient RP-HPLC method has been developed for simultaneous estimation of clobazam and its related substances in oral suspension. The chromatographic separation of degradation products and matrix components was executed on a YMC Pack ODS-A column with gradient mode. The mobile phase composed of water and acetonitrile and flow rate was 1.0 mL min-1, while 230 nm was wavelength of detection. The resolution greater than 2.0 between clobazam and the impurities was achieved. The forced degradation study was carried out as per ICH guidelines. The drug product

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Chakravarthy, V. Ashok, B. B. V. Sailaja, and Avvaru Praveen Kumar. "Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms." Journal of Analytical Methods in Chemistry 2015 (2015): 1–11. http://dx.doi.org/10.1155/2015/735145.

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The present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination enrofloxacin (EFX) and its degradation products including ethylenediamine impurity, desfluoro impurity, ciprofloxacin impurity, chloro impurity, fluoroquinolonic acid impurity, and decarboxylated impurity in tablet dosage forms. The separation of EFX and its degradation products in tablets was carried out on Kromasil C-18(250×4.6 mm, 5 μm) column using 0.1% (v/v) TEA in 10 mM KH2PO4(pH 2.5) buffe

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Xu, Ao, Yunlin Xue, Yuyu Zeng, et al. "Isolation and Characterization of an Unknown Process-Related Impurity in Furosemide and Validation of a New HPLC Method." Molecules 28, no. 5 (2023): 2415. http://dx.doi.org/10.3390/molecules28052415.

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Furosemide is a widely used loop diuretic in the treatment of congestive heart failure and edema. During the preparation of furosemide, a new process-related impurity G in the levels ranging from 0.08% to 0.13% was detected in pilot batches by a new high performance liquid chromatography (HPLC) method. The new impurity was isolated and characterized by comprehensive analysis of FT-IR, Q-TOF/LC-MS, 1D-NMR (1H, 13C, and DEPT), and 2D-NMR (1H-1H-COSY, HSQC, and HMBC) spectroscopy data. The possible formation pathway of impurity G was also discussed in detail. Moreover, a novel HPLC method was dev

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Mestareehi, Aktham H. "Optimized and Validated Stability-Indicating RP-HPLC Method for Comprehensive Profiling of Process-Related Impurities and Stress-Induced Degradation Products in Rivaroxaban (XARELTO)®." International Journal of Molecular Sciences 26, no. 10 (2025): 4744. https://doi.org/10.3390/ijms26104744.

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An isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method, coupled with photodiode array detection (PDA), was developed for the identification and characterization of stress degradation products and an unknown process-related impurity of rivaroxaban in bulk drug form. Rivaroxaban, a selective and direct Factor Xa inhibitor, underwent forced degradation under hydrolytic (acidic, alkaline, and neutral), photolytic, thermal, and oxidative stress conditions, following the ICH’s guidelines. The drug displayed significant susceptibility to acid, base, and oxidative environme

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Aher, Kalyani J., Dr Rishikesh S. Bacchav, and Prof Smita S. Aher. "Impurities in Pharmaceutical Substances." International Journal of Pharmaceutical Research and Applications 10, no. 1 (2025): 562–69. https://doi.org/10.35629/4494-1001562569.

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The quality, safety, and effectiveness of pharmaceutical products are significantly impacted by impurities in active pharmaceutical ingredients (APIs). During the synthesis, production, and storage processes, these impurities may originate from a number of sources, such as pollutants, reagents, residual solvents, and degradation products. International regulatory bodies including the FDA, EMA, and ICH strictly control the presence of impurities in APIs and offer detailed recommendations on permissible impurity levels and testing procedures. For the detection and measurement of contaminants, an

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Lawande, Appasaheb Bajirao. "SEPARATION AND DETERMINATION OF THE R-ISOMER OF ETODOLAC IN A BULK DRUG SUBSTANCE BY NORMAL-PHASE LIQUID CHROMATOGRAPHY." Asian Journal of Pharmaceutical and Clinical Research 9, no. 6 (2016): 327. http://dx.doi.org/10.22159/ajpcr.2016.v9i6.14597.

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ABSTRACT Objective: The objective of the this work is to develop and validate a novel, simple,rapid and reliable analytical method for separation and determination of R-isomer impurity in Etodolac bulk drug material by normal-phase high-performance liquid chromatography as per International Conference on Harmonization guidelines. Methods: The Etodolac R- isomer and S-isomer were separated on a Chiralcel OD-H (150 x 4.0 mm, 5 micron) column by using Ethanol : n-Hexane:Trifluoroacetic acid (50:50:0.1 v/v.) mobile phase with equipped detector at wavelength 225 nm and 25 °C column oven temperature

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Naguib, Ibrahim A., Nessreen S. Abdelhamid, Basma H. Anwar, and Maimana A. Magdy. "Three Spectrophotometric Methods for Quantitative Analysis of Duloxetine in Presence of its Toxic Impurity: 1-Naphthol." Journal of AOAC INTERNATIONAL 103, no. 4 (2020): 972–79. http://dx.doi.org/10.1093/jaoacint/qsz032.

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Abstract Background Duloxetine hydrochloride (DUL) is a drug used to treat depression and anxiety. 1-Naphthol is a potential toxic impurity of DUL, as it causes hepatotoxicity in humans, and it is harmful to aquatic life. Objective Three simple, selective, rapid, accurate and precise methods were developed and validated according to International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision and selectivity for analysis of duloxetine hydrochloride (DUL) in the presence of its potential toxic impurity 1-Naphthol in different laboratory-prepared mixt

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Jinesh, Bahubali Nagavi, and Gurupadayya Bannimath. "Stability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection." Pharmaceutical Methods 8, no. 1 (2017): 01–09. https://doi.org/10.5281/zenodo.14854615.

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Introduction: In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed and validated according to ICH guidelines. Methodology: The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chromatography with PDA detection. The maximum detection was set as follows: 237 nm for aspirin, its impurities and for the impurity C of cl

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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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Veeraswami, Boddu, and Rayala Ramarao. "Identification and Validation of Genotoxic Impurity in Ezetimibe by Reverse Phase High-Performance Liquid Chromatography." Oriental Journal Of Chemistry 39, no. 4 (2023): 896–903. http://dx.doi.org/10.13005/ojc/390410.

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The method emphasizes identification and validation of potential Genotoxic impurity in pharmaceutical drug substances of Ezetimibe by Reverse Phase High-Performance Liquid Chromatography (HPLC). The impurity was separated by using the Zorbax Rx Octylsilane (C8) HPLC column with 250 cm length and internal diameter of 4.6 mm with pore size 5 μm. The partition of impurity was operated at a significant pH 3.0 was maintained by buffer of 10% potassium dihydrogen phosphate and Acetonitrile with 80:20 ratio and the mobile phase is Acetonitrile with a gradient inflow of 1.5 mL/min. The UV absorption m

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

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

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Chaudhari, Yogesh Jagdish, Rama Sadashiv Lokhande, and Ravi Ramrathi Yadav. "Stability Indicating Method Development, Validation and Forced Degradation Study for Vilazodone Hydrochloride API." Oriental Journal Of Chemistry 37, no. 1 (2021): 204–12. http://dx.doi.org/10.13005/ojc/370128.

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The current study describes the short, stability indicative HPLC method development and successive validation of Assay and Related Substances methods for Vilazodone Hydrochloride API. This study also covers Vilazodone process impurities viz. Impurity A and Impurity B. The chromatographic conditions for Related Substances and Assay are similar except sample concentration. The proposed method utilizes C18 column (15 cm X 4.6 mm, 5 µ, make ZORBAX SB) and mobile phase having Methanol and 0.05 M KH2PO4 (55: 45 v/v). The separation between all three analytes was achieved in less than five minutes. T

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Subbaiah, Nelaturi, and Gopireddy Venkata Subba Reddy. "A SELECTIVE AND SENSITIVE METHOD DEVELOPMENT AND VALIDATION BY LC-MS/MS APPROACH FOR TRACE LEVEL QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITY OF BOC EPOXIDE IN ATAZANAVIR SULPHATE DRUG SUBSTANCE." International Journal of Pharmacy and Pharmaceutical Sciences 9, no. 9 (2017): 143. http://dx.doi.org/10.22159/ijpps.2017v9i9.20248.

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Objective: To develop and validate a selective, sensitive, rapid and accurate method using LC-MS/MS technique to achieve efficient separation between active pharmaceutical ingredient (Atazanavir sulphate) and genotoxic impurity (BOC epoxide).Methods: The quantification was carried out using the column puro sphere star RP 18 e (length 150 mm, internal diameter 4.6 mm, particle size 3.0 µm) with electrospray ionization in multiple reaction monitoring (MRM) detection mode. Eluent-A was 0.1% formic acid in water and eluent-B was 0.1% formic acid and 0.1% ammonium hydroxide solution (25%) in aceton

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Mo, Firoj Tanwar, Agrawal Dilip, and Mandal Sulekha. "To Develop and Validation of RP-HPLC Method for Estimation of Mycophenolate Mofetil in Pure and Pharmaceutical Tablet Dosage." International Journal of Current Pharmaceutical Review and Research 15, no. 06 (2023): 158–66. https://doi.org/10.5281/zenodo.12582632.

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AbstractThe present work is aimed at development and validation of RP HPLC method which issimple, specific, precise, and accurate for estimation of Mycophenolate Mofetil and itsprocess-related impurity in bulk and pharmaceutical dosage forms. Extensive literaturesurvey revealed no method for estimation of the above said. The characterization ofsynthesized impurities detected by using FTIR, NMR and MS. The RP-HPLC method wasdeveloped according to ICH Q2B guidelines for quantitation of impurity in bulk andformulations. The method was validated as per ICH guidelines. The method was found to belin

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Manivannan, M., P. Parthiban, and P.Ilayaraja. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GENOTOXIC IMPURITY p-ANISALDEHYDE IN TENELIGLIPTIN USING GC-MS." RASAYAN Journal of Chemistry 15, no. 03 (2022): 1855–60. http://dx.doi.org/10.31788/rjc.2022.1536954.

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This research aimed to develop a sensitive GC–MS (Gas Chromatography-Mass Spectrometry) technique for the estimation of genotoxic impurity p-anisaldehyde in Teneligliptin drug to meet the current regulatory requirements. A simple and specific method was developed and validated according to ICH (International Council for Harmonization) guidelines. The LOQ (limit of quantitation) and LOD (limit of detection) values were determined as 0.38 and 0.12 ppm, respectively. The approach was linear in the range of 0.38–56 ppm with a correlation coefficient of 0.9997. The average recovery of Teneligliptin

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Sharma, Pushpendra, KLV Satyanarayana, and G. Sri Hari. "Cost Effective, Efficient and Stability indicating analytical method validation for Ranolazine related by Reverse Phase High Performance Liquid Chromatography in drug substances." Journal of Drug Delivery and Therapeutics 10, no. 6-s (2020): 45–54. http://dx.doi.org/10.22270/jddt.v10i6-s.4446.

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A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Ranolazine in drug substances. Isocratic elution at a flow rate of 1.4ml/min was employed on Hypersil BDS C18, 150 x 4.6 mm, 5µm or Equivalent at 40°C column temperature. The mobile phase consisted of Mobile phase-A: Mobile phase-B (55:45) (Disodium hydrogen orthophosphate buffer with pH 7.0 and Acetonitrile). The UV detection wavelength was at 205 nm. Linearity was observed in concentration range of 0.07-0.82 ppm for ranolazine impurity-I and concentration range of 0.07-0.78 ppm for

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Chittireddy, Hari Naga Prasada Reddy, J. V. Shanmukha Kumar, Anuradha Bhimireddy, et al. "Development and Validation for Quantification of 7-Nitroso Impurity in Sitagliptin by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry." Molecules 27, no. 23 (2022): 8581. http://dx.doi.org/10.3390/molecules27238581.

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The purpose of this research study was to develop an analytical method for the quantification of 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4] triazolo [4,3-a] pyrazine (7-nitroso impurity), which is a potential genotoxic impurity. Since sitagliptin is an anti-diabetic medication used to treat type 2 diabetes and the duration of the treatment is long-term, the content of nitroso impurity must be controlled by using suitable techniques. To quantify this impurity, a highly sensitive and reproducible ultraperformance liquid chromatography with triple quadrupole mass spectrometry (UHPLC

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Naguib, Ibrahim A., Eglal A. Abdelaleem, Aml A. Emam, and Fatma F. Abdallah. "Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma." Journal of Chromatographic Science 57, no. 7 (2019): 653–61. http://dx.doi.org/10.1093/chromsci/bmz043.

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Abstract A green, accurate and specific high-performance thin-layer chromatographic (HPTLC) method was developed and validated for simultaneous quantitative determination of pyridostigmine bromide (PR), impurity B (IMP B);3-hydroxy-N-methylpyridinium bromide and impurity A (IMP A); pyridin-3-yl-dimethylcarbamate. The two pharmacopeial impurities are also its main inactive metabolites. Furthermore, IMP B is known to be its alkaline-induced degradation product. Achievable separation of the studied components required silica gel HPTLC F254 plates as a stationary phase and acetone: acetic acid (80

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Hemchand, S., R. Ravi Chandra Babu, and Mukthinuthalapati Mathrusri Annapurna. "A new validated stability-indicating gradient RP-HPLC method for the determination of pemetrexed disodium and its process related substances." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 588–610. http://dx.doi.org/10.22270/jddt.v9i3-s.2918.

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Pemetrexed disodium is used for the treatment of malignant pleural mesothelioma and lung cancer. In the present study a simple stability indicating RP-HPLC method was developed and validated for the determination of Pemetrexed disodium. The process related substances such as Dimer-1 impurity, Dimer-2 impurity, N-Methyl Pemetrexed, Pemetrexed diethyl ester, Alanine derivative of Pemetrexed, DMF derivative of Pemetrexed, Acid intermediate, Oxidation impurity and D-isomer were separated on gradient mode and quantified. Forced degradation studies were performed to prove the specificity. Hypersil B

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Shinde, P., S. Shirke, R. Dwivedi, and U. Dhuppad. "A NOVEL HPLC METHOD FOR ESTIMATION OF GENOTOXIC IMPURITY 3-ACETAMIDOBENZENE 1, 2 DICARBOXYLIC ACID IN KEY STARTING MATERIAL 3-ACETAMIDOPTHALIC ANHYDRIDE OF APREMILAST API." INDIAN DRUGS 55, no. 05 (2018): 42–46. http://dx.doi.org/10.53879/id.55.05.10932.

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3-Acetamidobenzene -1, 2-dicarboxylic acid is a potential genotoxic impurity which gets formed during synthesis of 3- acetamidopthalic anhydride, a Key Starting Material (KSM) for manufacturing of apremilast API. During handling upon exposure to moisture, the anhydride ring of KSM 3-acetamidopthalic anhydride opens to form the acid. Hence Reverse phase HPLC method is not a feasible and robust option for estimation of this impurity. To overcome these problems a normal phase HPLC method is developed and proposed in this research work. Immobilized Chiral pack IA column from Daicel is used for est

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Narapereddy, Krishan Prasad, and Devi Sravanthi Alladi. "Development and validation of determination of genotoxic impurity Bromoethane in Vigabatrin drug substance using head space gas chromatographic method [HS-GC]." Pharmacia 70, no. (1) (2023): 203–7. https://doi.org/10.3897/pharmacia.70.e97339.

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A specific HS-GC method has been developed, optimized, and validated for the determination of genotoxic impurity Bromoethane in Vigabatrin (VGB) drug substance. Chromatographic separation of genotoxic Bromoethane impurity was achieved on DB-1 column (30 m × 0.53 mm, 5.0 μm), consists of 100% dimethyl polysiloxane as stationary phase and passing nitrogen carrier gas. The performance of the method was assessed by evaluating the specificity, linearity, sensitivity, precision, and accuracy experiments. The established limit of detection and limit of quantification values for the genotoxic impurity

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Amit, Gosar, Joglekar Amit, Shaikh Tabrez, Mhatre Sandeep, and Patil Swapnil. "Development of a Highly Sensitive Method for Quantitative Estimation of Dimethyl Sulfate Impurity in Neostigmine Methylsulfate Drug substances by Using GC-MS." Journal of Pharma and Drug Regulatory Affairs 1, no. 2 (2019): 25–29. https://doi.org/10.5281/zenodo.3248738.

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<em>A selective and highly sensitive gas chromatography-mass spectrometry (GC-MS) method was developed for the determination of Dimethyl Sulfate (DMS) impurity in Neostigmine Methylsulfate drug substance. The method was validated as per International Council for Harmonisation (ICH) guidelines, for which limit of detection and limit of quantitation obtained were 25.48 ppm and 77.20 ppm, respectively. The regression coefficient found for the linearity study was 0.9986. The recovery of the spiked Dimethyl Sulfate in drug substance obtained was in the range of 84.40% to 88.24% ensured the accuracy

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Jagdishbhai, Shah Utsav, and Dr Bhaveshkumar H. Patel. "Impurity Profiling of Some Anti-Cancer Drugs/Capivasertib." South Eastern European Journal of Public Health, February 11, 2025, 3207–20. https://doi.org/10.70135/seejph.vi.4455.

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A simple, specific, accurate and precise stability-indicating reversed-phase liquid chromatographic method had been developed and validated as per ICH guideline for Estimation of Capivasertib in its pharmaceutical dosage form. Also, a forced degradation study of Capivasertib was carried out including acid, alkali, peroxide, reduction, thermal and hydrolysis. The method was based on isocratic elution using a mobile phase consisting of Acetonitrile : 0.1% Triethyl Amine (50:50 % v/v) pH 2.5 / Formic acid at a flow rate of 1.2 ml /min with Kromasil C18 (150 mm x 4.6 mm, 5µm) column. Detection wav

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Dahiya, Dev Prakash, Geetanjali Saini, Amit Chaudhary, et al. "A Comprehensive Review of Quantifications, Profiling, and Regulations of Pharmaceutical Impurities." Journal of Pharmaceutical Research International, December 28, 2021, 194–222. http://dx.doi.org/10.9734/jpri/2021/v33i62a35200.

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In the past few decades impurity profiling has continuously gained the attention of regulatory bodies due to the rise in the number of drugs frequently entering the market. International regulatory agencies like ICH, FDA, Canadian Drug and Health Agency emphasize carrying out impurity profiling of drugs in strict compliance with the regulatory guidelines that have been laid down intending to ensure production of high quality and safe pharmaceutical drugs to serve mankind. Simple impurities can be easily evaluated by conventionally available methods whereas impurities present within complex mat

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R. Soni, Nirav, and Pragnesh Patani. "Impurities Profiling of Method Development and Validation of Etravirine (ETR) in their Dosage Forms by Chromatography Method as Per International Conference on Harmonisation Guidelines." Indian Journal of Pharmaceutical Sciences, 2024, 524–30. https://doi.org/10.36468/pharmaceutical-sciences.16.6.524-530.

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Objective: An accurate, precise, rapid and economical reverse phase High Performance Liquid Chromatography (HPLC) method has been developed and validated for the estimation of etravirine in pharmaceutical dosage forms, using PDA detector. Method: Elution was carried out using a mobile phase-A and B consisting of HPLC grade and flow rate was set on 1 ml/minute at 310 nm wave length. The retention time for Etravirine (ETR), impurity-1 and impuriey-2 was found to be 15.813, 12.043 and 17.704 respectively minutes. Result: Analytical method was developed using HPLC Shimadzu (with power stream) grad

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KONDRA, SRINIVASU, BAPUJI A. T., D. GOWRI SANKAR, and POTTURI MURALI KRISHNAM RAJU. "IMPURITY PROFILING IMPURITY PROFILING OF THIAMINE HYDROCHLORIDE INJECTION BY RP-HPLC AND CHARACTERIZATION OF DEGRADATION PRODUCT BY LC-MS/MS/QTOF." International Journal of Applied Pharmaceutics, September 16, 2020, 151–61. http://dx.doi.org/10.22159/ijap.2020v12i6.38283.

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Objective: To propose a comprehensive, simple, and affordable RP-HPLC method for impurity profiling and characterization of unknown degradation products of thiamine hydrochloride injectable formulation. Methods: The chromatographic separation employs gradient mode using the octadecyl silane column using a mobile phase consisting of phosphate buffer with ion pair reagent, acetonitrile, and methanol delivered flow rate at 1.2 ml/min. The detection was carried out at 248 nm using empower software. LC-MS/MS/QTOF hyphenated technique was used for isolation and characterization of unknown degr

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PRAGATI J. VANAVI and SADHANA J. RAJPUT. "IMPURITY PROFILING OF FIRST LINE ANTI-TB DRUG-TERIZIDONE USING CHROMATOGRAPHIC AND RELATED TECHNIQUES." International Journal of Pharmacy and Pharmaceutical Sciences, May 1, 2021, 83–95. http://dx.doi.org/10.22159/ijpps.2021v13i5.40918.

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Objective: The objective of the present study was to investigate the stability of TRZ against different stressors and to prepare impurity profile for potential impurities and degradation products (DPs) formed under stress degradation of TRZ bulk drug and formulation. Methods: Three analytical methods were developed; the stability-indicating method that was developed using HPLC instrument with 0.01M ammonium acetate buffer (pH 4.0 using glacial acetic acid (GAA)) and acetonitrile in gradient program. The second method was a UPLC/ESI-MS method using 0.1 % Formic acid in Milli Q water (pH=

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Bahgat, Eman A., Hisham Hashem, Hanaa Saleh, Ebraam B. Kamel, and Maya S. Eissa. "Exciting Advances in Sustainable Spectrophotometric Micro-Quantitation of an Innovative Painkiller “Tramadol and Celecoxib” Mixture in the Presence of Toxic Impurity, Promoting Greenness and Whiteness Studies." Journal of AOAC International, December 9, 2023. http://dx.doi.org/10.1093/jaoacint/qsad133.

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Abstract Background Tramadol (TRM) and celecoxib (CLX) are a novel mixture that helps relieve impetuous, acute pain when other painkillers have no action. It is also reported that the currently studied drugs, tramadol and celecoxib, are used to control COVID-19 symptoms. Objective The current work highlights three important pillars of modern pharmaceutical analysis, which are as follows; impurity profiling, greenness/whiteness studies and simplicity accompanied by sensitivity. Since 4-methyl acetophenone inhibits the human carbonyl reductase enzyme (type I), and since this compound may pose a

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MAHAJAN, NITIN, SUPARNA DESHMUKH, and MAZAHAR FAROOQUI. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR KNOWN AND UNKNOWN IMPURITIES PROFILING FOR CARVEDILOL PHARMACEUTICAL DOSAGE FORM (TABLETS)." International Journal of Current Pharmaceutical Research, November 15, 2021, 71–80. http://dx.doi.org/10.22159/ijcpr.2021v13i6.1922.

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Objective: The aim of the research work to develop a simple, sensitive, rugged, robust and specific novel gradient stability indicating reverse phase HPLC method for quantitative determination of known and unknown impurities profiling of Carvedilol pharmaceutical dosage forms (Tablets). Methods: Chromatographic separation has been achieved on an Inertsil ODS 3V column (150 mm x 4.6 mm, 5μm) with mobile phase consisting Mobile phase-A (Water, Acetonitrile and Trifluroacetic acid in the ratio of 80:20:0.1 v/v/v respectively and pH adjusted to 2.0 with dilute potassium hydroxide solution) a

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