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Journal articles on the topic 'Genotoxic impurities and Method validation'

Author: Grafiati

Published: 5 June 2025

Last updated: 1 August 2025

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1

Siva, Krishna Nachaka, Babu Kodavati Ramesh, Vaidyanathan Gopal, Paila Sattibabu, and Palnati Narmada. "Quantitative Determination of Trace Levels of Nitromethane and Its Analog Impurities by Using HS-GC-MS." American Journal of PharmTech Research 12, no. 4 (2022): 48–64. https://doi.org/10.5281/zenodo.7124322.

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ABSTRACT A specific HS-GC-MS method has been developed, optimized and validated for the determination of five genotoxic impurities namely Nitromethane, Nitroethane, 2-Nitropropane, 1-Nitropropane and 1-Nitrobutane in TRB-G, intermediate of Trabectedin drug substance. Chromatographic separation of five genotoxic impurities was achieved on Capillary GC column (Rtx-1701. Fused silica capillary column; 30 m length; 0.25mm internal diameter. coated with 14% Cyanopropylphenyl and 86% dimethyl polysiloxane stationary phase of 1.0 µm film thickness) and passing helium carrier gas with Electron I

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N, Balaji, and Sayeeda Sultana. "ULTRA-HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC DETERMINATION OF GENOTOXIC IMPURITIES IN FEBUXOSTAT DRUG SUBSTANCE AND PRODUCTS." Asian Journal of Pharmaceutical and Clinical Research 10, no. 1 (2016): 324. http://dx.doi.org/10.22159/ajpcr.2017.v10i1.15381.

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ABSTRACTObjective: An efficient ultra-high performance liquid chromatographic (UHPLC or Infinity LC 1290) method has been developed and validated for thequantification of possible carcinogenic or genotoxic impurities in febuxostat drug substances and drug products at 18 µg/ml level.Methods: This method includes the conclusion of four potential genotoxic impurities in febuxostat. The mobile phase is trifluoroacetic acid,acetonitrile, and water with linear gradient elution. The UHPLC column used for the analysis was zorbax RRHD eclipse plus C18 with a length of100 mm, internal diameter of 2.1 mm

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Balaji, N., and Sayeeda Sultana. "TRACE LEVEL DETERMINATION AND QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITIES IN DASATINIB DRUG SUBSTANCE BY UHPLC/INFINITY LC." International Journal of Pharmacy and Pharmaceutical Sciences 8, no. 10 (2016): 209. http://dx.doi.org/10.22159/ijpps.2016v8i10.14020.

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<p class="Default"><strong>Objective: </strong>A simple, cost-effective and mass compatible ultra-high fast performance liquid chromatographic (Agilent-Infinity LC 1290) method has been developed and validated for the determination of potentially genotoxic impurities in dasatinib active pharmaceutical ingredients.</p><p class="Default"><strong>Methods: </strong>This method comprises the determination of three possible genotoxic impurities in dasatinib. The mobile phase is trifluoroacetic acid, acetonitrile and water with linear gradient elution curve n

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M. Manivannan, P. Ilayaraja, and P. Parthiban. "GC-MS METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF GENOTOXIC TOSYLATES IN TENELIGLIPTIN." RASAYAN Journal of Chemistry 18, no. 03 (2025): 1696–703. https://doi.org/10.31788/rjc.2025.1839365.

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In this study, a specific and robust Gas Chromatography-Mass Spectrometry (GC-MS) method was meticulously developed, optimized, and validated for the precise determination of the genotoxic tosylate impurities in Teneligliptin. The method was optimized on an Agilent 5977B GC/MSD system equipped with a capillary column (HP-5MS, 30 m × 0.32 mm x 1.0 μm) using helium as the carrier gas. Detection of the impurities was achieved using selective ion monitoring mode at specific mass-to-charge ratios. The method excelled in validation for various parameters, including specificity, sensitivity, precisio

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5

Patel, Haresh B., Rohit H. Dave, Sandip Vadariya, Hitin Hirpara, and Trushar Patel. "Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances." Biotechnology Journal International 28, no. 4 (2024): 1–17. http://dx.doi.org/10.9734/bji/2024/v28i4724.

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The assessment of toxicological concentrations of possible genotoxic contaminants in drug substances was regarded as an important and challenging discipline . The International Conference and Harmonization (ICH) recommended that most pharmaceutical products be allowed to include 1.5 μg/day of a genotoxic contaminant. The goal study was to develop a quick and accurate HPLC method for measuring potential genotoxic impurities (PGIs) in Dapson drug substances. The chromatographic conditions were appropriately optimized with the Phosphate and Acetate buffer on C18 & C8 columns to achieve a dece

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Rao P.Y.G, Sreenivasa Rao B, Suresh Reddy K.V.N, and Sudhakar Ch. "A Selective and Sensitive Method for Simultaneous Quantification of Genotoxic Impurities in Penciclovir drug substance and its dosage forms using UPLC-MS/MS." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 5772–76. http://dx.doi.org/10.26452/ijrps.v11i4.3224.

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A selective, rapid and sensitive method was developed for the determination of genotoxic impurities (2-Amino-6-chloro purine and Bromo compound) in Penciclovir drug substance using RPUPLC-MS/MS. The chromatographic separation was performed on Kromasil C8 column (150 mm x 4.6 mm, 5 μm) maintained at 45°C using 0.1%formic acids in water as buffer and acetonitrile through gradient programme. The flow rate was maintained at 0.5mL/min with an injection volume of 10 μL. For the quantification of genotoxic impurities, positive-electrospray ionisation (ESI) mode was selected. Penciclovir and its impur

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7

Suresh Kumar and Akash Singh Pawar. "Formation of nitrosamine impurities: Discussion and advanced method development and validation using LC-MS/MS for their detection." World Journal of Biology Pharmacy and Health Sciences 20, no. 3 (2024): 385–89. https://doi.org/10.30574/wjbphs.2024.20.3.1016.

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Nitrosamine impurities, known for their genotoxic and carcinogenic potential, have emerged as critical concerns in pharmaceutical manufacturing. Their presence in various drug substances and products has led to stringent regulatory actions globally. This report explores the formation mechanisms of nitrosamine impurities, including the subset of nitrosamine drug substance-related impurities (NDSRIs), which arise from API-specific interactions. Advanced analytical techniques such as LC-MS/MS, GC-MS/MS, and HRMS are reviewed for their efficacy in detecting and quantifying these impurities. The re

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Mohan, Bavireddi, Ramayanam Siva Kameswara Sharma, Devarakonda Ravi Kumar, Seshagiri Vijaya Murali Mohan Rao, and Nutulapati Venkata Satya Venugopal. "Determination of Genotoxic alkyl p-toluene Sulfonates in Cabazitaxel using LC-MS Method." Current Pharmaceutical Analysis 15, no. 7 (2019): 753–61. http://dx.doi.org/10.2174/1573412915666190522085818.

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Introduction: A suitable LC-MS method for the quantitative determination of genotoxic impurities such as alkyl p-toluene sulfonates in Cabazitaxel was developed. Alkyl p-toluene sulfonates were estimated by LC-MS method using Waters Symmetry C18 (75×4.6 mm), 3.5 µ column. Materials and Methods: Column temperature was maintained 40 °C. Injection volume was 10 µL and flow rate was set as 0.8 mL/min. Sampler temperature was maintained to 25 °C and run time was set as 25 minutes. The mobile phase was a mixture of ammonium acetate buffer and acetonitrile in 70:30(v/v) was used. Results: The method

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Vadlamani, Annapoorna, K. Ravindhranath, and B. Sreenivasa Rao. "Detection and Quantification of Two Potential Genotoxic Impurities in Telbivudine Active Pharmaceutical Ingredient by Targeted Ultra Performance LC-MS/MS Analysis." Asian Journal of Chemistry 34, no. 12 (2022): 3383–90. http://dx.doi.org/10.14233/ajchem.2022.26905.

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A new selective, rapid and highly sensitive method using reversed-phase ultra-performance liquid chromatography (RP-UPLC) coupled with mass analyzer was developed for the detection and quantification of two genotoxic impurities viz. 4-dimethyl aminopyridine (GTI-1) and 2-bromo-3,5-diacetyl thymidine (GTI-2) in Telbivudine drug substance. The separation of two genotoxic impurities was accomplished using Kromasil C8 column (100 mm × 4.6 mm, 3.5 μm) maintained at 45 ºC using formic acid (0.1%) as buffer solution and gradient grade acetonitrile with 0.5 mL/min flow rate. Both GTIs were quantified

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M., Manivardhan Reddy*1 G. Sampath Kumar Reddy2 and K. Ramadevi3. "Comprehensive Insights into High-Performance Liquid Chromatography for Pharmaceutical Analysis: Focus on Genotoxic Impurities." International Journal of Pharmaceutical Sciences 3, no. 1 (2025): 2031–46. https://doi.org/10.5281/zenodo.14729254.

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High-Performance Liquid Chromatography (HPLC) is a crucial analytical technique widely employed in the pharmaceutical industry for the identification, quantification, and control of genotoxic impurities (GTIs). These impurities, such as nitrosamines, pose significant public health risks due to their carcinogenic potential, necessitating precise detection and stringent regulatory control. This review explores the fundamentals of HPLC, including its principles, instrumentation, operational methodologies, and various applications in pharmaceutical analysis. It emphasizes the development and valid

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Rao K, L. Narasimha, N. Devanna, and K. v. n. Suresh Reddy. "METHOD DEVELOPMENT AND VALIDATION STUDY FOR QUANTITATIVE DETERMINATION OF GENOTOXIC IMPURITY AND ITS PRECURSOR IN FLUCONAZOLE SAMPLE BY LIQUID CHROMATOGRAPHY–TANDEM MASS SPECTROMETRY." International Journal of Pharmacy and Pharmaceutical Sciences 8, no. 12 (2016): 84. http://dx.doi.org/10.22159/ijpps.2016v8i12.14727.

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<p><strong>Objective: </strong>The objective of this work is method development and validation study for quantitative determination of 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-triazole, a genotoxic impurity and its precursor in a fluconazole drug sample by liquid chromatography–tandem mass spectrometry.</p><p><strong>Methods: </strong>LC-MS/MS analysis of these impurities was performed on Hypersil BDS C18 (100 mm x 4.0 mm, 3 µm) column. 5 mmol ammonium acetate and acetonitrile in the ratio of 65:35 (v/v) was used as the mobile phase with a f

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Chadwick, James, Anne Kelly, and Emma Quirk. "The use of glutathione as a derivatising agent for the analysis of Michael acceptor genotoxic impurities in pharmaceuticals." Analytical Methods 9, no. 10 (2017): 1603–10. http://dx.doi.org/10.1039/c7ay00158d.

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13

Rao Anna, Venkateswara, V. K. Rohini, K. Hemabala, Bhagya Kumar Tatavarti, and Vijaya N. "Evaluation of New Degradation Products Formed Under Stress Conditions of Betrixaban by LCMS/MS: Establishment of HPLC Method for Quantification of Genotoxic Impurities of Betrixaban." International Journal of Advancement in Life Sciences Research 07, no. 04 (2024): 64–78. http://dx.doi.org/10.31632/ijalsr.2024.v07i04.006.

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This study focused to optimize an accurate HPLC method for evaluation of genotoxic impurities of Betrixaban and further structural identification of forced degradation products (DPs) of betrixaban. The analytes were resolved on Zorbax SB C18 (4.6×250mm, 5μm, Agilent) column at 35°C temperature using 75 % aqueous ammonium formate (5 mM) and 50 % ammonium formate in acetonitrile in 60:40 (v/v) in isocratic elution at 1.0 mL/min and 245 nm as detection wavelength. In the optimized experimental conditions, the retention times of the analytes were precisely determined, resulting in retention times

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Amit B Bhosale , Ravi Yadev, Seema Kothari. "Development and Validation of Headspace-Gas Chromatography (HS-GC) Method for the Determination of Potential Genotoxic Impurities in Meloxicam." Tuijin Jishu/Journal of Propulsion Technology 44, no. 4 (2023): 3541–59. http://dx.doi.org/10.52783/tjjpt.v44.i4.1495.

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The development and validation of a specific Headspace-Gas Chromatography (HS-GC) method for the determination of genotoxic impurities (isopropyl chloride, propionaldehyde, 2-chloropropanol, and chloromethane) in Meloxicam. The chromatographic separation of these impurities was accomplished using a nitrogen carrier gas on a DB-624 (6% cyanopropyl phenyl + 94% dimethyl polysiloxane fused silica) (75 m x 0.53 mm, 3.0 µ) GC analytical column. The Flame Ionization Detector (FID) served as the detector with optimized temperatures set at 260°C for the detector and 240°C for the injector port. Additi

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Gaddam, Kishore, Shanker Kanne, Trivikram Reddy Gundala, Yogeshwar Reddy Mamilla, and Gangi Reddy Nallagondu Chinna. "Determination of Possible Potential Genotoxic Impurities in Lenalidomide Drug Substance by Simple RP-HPLC Method." Asian Journal of Chemistry 32, no. 12 (2020): 2965–70. http://dx.doi.org/10.14233/ajchem.2020.22856.

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This study is concerned with development and validation of HPLC method for the simultaneous detection and quantification of methyl 2-(chloromethyl)-3-nitrobenzoate (MCN), methyl 2-(bromomethyl)-5-nitrobenzoate (MMM), methyl 2-(bromomethyl)-6-nitrobenzoate (MON), methyl 2-(bromomethyl)-4-nitrobenzoate (MPN) and 2-methyl-3-nitrobenzoic acid methyl ester (MNM), which are the genotoxic impurities of lenalidomide. Chromatographic separation was accomplished using a Waters HPLC system equipped with Ascentis Express F5 (150 × 4.6 mm, 2.7 μm) using mobile phase composed of solvent A (0.1% perchloric a

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Chen, Yuyuan, Song Wu, and Qingyun Yang. "Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials." Journal of Analytical Methods in Chemistry 2020 (March 9, 2020): 1–8. http://dx.doi.org/10.1155/2020/6597363.

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Pantoprazole sodium (PPZS) is a selective proton pump inhibitor used in the prevention and treatment of gastric acid-related diseases. Six potentially genotoxic impurities (PGIs) are involved in 5-difluoromethoxy-2-mercapto-1H-benzimidazole (DMBZ), which is the starting material of PPZS. To date, no suitable method has yet been developed for PGI separation and quantification at the threshold of toxicological concern levels. In this study, a sensitive and reliable liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative analysis of six PGIs in DMBZ

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17

Shaik, Mohammed Ameen Basha, and Shahidha Bee S. "A new method of development and validation of Methanesulfonic acid ester (Methyl, Ethyl) impurity content in dabigatran etexilate mesylate by GC MS." International Journal of Experimental and Biomedical Research 3, no. 3 (2024): 35–39. http://dx.doi.org/10.26452/ijebr.v3i3.638.

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We attempted to establish a method for estimating methane sulfonic acid methyl or ethyl ester in the dabigatran etexilate Mesylate in bulk and pharmaceutical dosage form. Dabigatran is an anticoagulant used in deep vein thrombosis and lung thrombosis. Methane sulfonic acid and ethyl sulfonic acid are DNA ethylating agents and genotoxic. These compounds can be estimated using the GC MS method using Helium as a carrier gas, and the compounds are estimated to be at 79 and 400 masses. The 60% methanol is used as diluent and blank. The method is validated as per the procedures of ICH, and all the v

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Annapoorna, Vadlamani, K. Ravindhranath, and Rao B. Sreenivasa. "A highly sensitive and selective method for the development and validation of potential genotoxic impurity in Raltegravir by high-throughput UPLC-MS/MS." Research Journal of Chemistry and Environment 26, no. 10 (2022): 142–52. http://dx.doi.org/10.25303/2610rjce1420152.

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Raltegravir is a human immunodeficiency virus (HIV) integrase inhibitor, a novel anti-AIDS drug. To quantify genotoxic impurities (GTIs), conventional analysis techniques are inadequate as a result, there is a high need to develop critical analytical methods for drug analysis using the hyphenated analytical technique. A highly sensitive and selective method was developed and validated for the estimation of genotoxic impurity in Raltegravir Active pharmaceutical ingredient (API) by using UPLC-MS/MS. The UPLC-MS/MS analysis for the quantification of GTI was performed on the symmetry C18 (150 mm×

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Srinu, Deshoju, G. Sampath Kumar Reddy, and B. Jainendra Kumar. "ADVANCES IN GAS CHROMATOGRAPHY FOR DETECTING PROCESS IMPURITIES: A COMPREHENSIVE REVIEW ON METHOD DEVELOPMENT, VALIDATION, AND SCALABILITY." International Journal of Advanced Research 13, no. 01 (2025): 61–67. https://doi.org/10.21474/ijar01/20164.

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Background:Gas chromatography (GC) remains a cornerstone in analytical chemistry, extensivelyemployed for the detection and quantification of process impurities, including volatile organic compounds (VOCs) and genotoxic impurities (GTIs) in pharmaceutical and industrial applications. Main Body:This review examines the evolution of conventional GC techniques with a focus on method development and validation in line with International Council for Harmonisation (ICH) guidelines. Special emphasis is placed on nitrosamines, scalability, cost-benefit analysis, and the integration of advanced technol

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Chittireddy, Hari Naga Prasada Reddy, J. V. Shanmukha Kumar, Anuradha Bhimireddy, et al. "Development and Validation for Quantitative Determination of Genotoxic Impurity in Gemfibrozil by Gas Chromatography with Mass Spectrometry." Separations 10, no. 3 (2023): 145. http://dx.doi.org/10.3390/separations10030145.

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All regulatory organizations are paying close attention to the identification and measurement of genotoxic contaminants. Using conventional analytical techniques like high-performance liquid chromatography (HPLC) and gas chromatography to quantify probable genotoxic substances (PGIs) at the trace level is difficult (GC). Therefore, there is a necessity for advanced analytical techniques for the development of highly sensitive analytical procedures for the determination of trace-level PGIs in drug products and drug substances. This study’s goal is to develop and evaluate an analytical technique

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Pathak, Mehul, Dhara D. Patel, Dalip Sharma, Avineesh Singh, and Suresh Agrawal. "Trace Level Quantification of Genotoxic Impurities through Atmospheric Pressure Chemical Ionization (APCI) Coupled with Triple Quardrapole Analyzer in Combination Diabetic Drug Product." Asian Journal of Chemistry 36, no. 4 (2024): 795–801. http://dx.doi.org/10.14233/ajchem.2024.31178.

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N-Nitrosamine impurities have been found in several drug products, showing a concern for regulatory aspects. The study presents the development and validation of a sensitive LC-MS/MS method for detecting eight nitrosamines in vildagliptin and metformin drug products. The developed method was specific and linearity was ranged 3.53-55.92 ppb for NDMA, 3.18-50.37 ppb for NMBA, 0.97-15.41 ppb for NDEA, 0.98-15.52 ppb for NEIPA, 1.00-15.86 ppb for NDIPA, 0.98-15.46 ppb for NDBA, 0.98-15.58 ppb for NMPA and 0.7-15.32 ppb for NDPA with correlation coefficient (r) was more than 0.98 and square of corr

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Chittireddy, Hari Naga Prasada Reddy, J. V. Shanmukha Kumar, Anuradha Bhimireddy, et al. "Development and Validation of Analytical Method Using Gas Chromatography with Triple Quadrupole Mass Spectrometry for the Detection of Alkyl Halides as Potential Genotoxic Impurities in Posaconazole." Separations 10, no. 5 (2023): 295. http://dx.doi.org/10.3390/separations10050295.

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Effective risk management and control methods for potentially genotoxic impurities (PGIs), including alkyl halides, are of significant importance in the medicinal (pharmaceutical) sector. The three alkyl halides in posaconazole are PGIs. The detection and assessment of genotoxic substances is a top priority for all regulatory organizations. Quantifying PGIs at trace levels using standard analytical techniques, such as gas chromatography (GC) and high-performance liquid chromatography (HPLC), is challenging for the pharmaceutical manufacturing industry. Thus, the detection of trace quantities o

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Patil, Santosh, Ketan Patel, Rajeev Chadar, et al. "Evaluation, Method Development, and Validation for Content Determination of Potential Genotoxic Impurities (PGIs) at the TTC Level in Telmisartan API." Organic Process Research & Development 25, no. 6 (2021): 1391–401. http://dx.doi.org/10.1021/acs.oprd.1c00086.

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Perla, Ganesh, Hemant M. Gandhi, N. Jagadeesh, et al. "METHOD DEVELOPMENT AND VALIDATION OF DIMETHYL SULPHATE CONTENT IN ESOMEPRAZOLE MAGNESIUM DRUG SUBSTANCE BY GC-MS." Journal of Applied Pharmaceutical Sciences and Research 6, no. 2 (2023): 8–15. http://dx.doi.org/10.31069/japsr.v6i2.02.

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Dimethyl sulfate is universally used as an alkylating, sulfating and sulfonating agent in organic synthesis; hence it is one of the probable impurities during the synthesis of the esomeprazole magnesium. As per ICH M7, it is genotoxic and mutagenic, so it needs to be controlled as per the acceptable intake of dimethyl sulfate and daily sample dosage. This method validation can be achieved by the hyphenated technique of gas chromatography with mass spectroscopy, which is used to develop the dimethyl sulfate impurity in esomeprazole magnesium drug substance containing salt. The method is achieve

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RV, Nagasurendra, and Devanna N. "A Rapid, Selective and Sensitive Electrospray Ionization Assisted LC-MS Method for Ranolazine and Identification of Its Two Potential Genotoxic Impurities." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 01 (2024): 228–33. http://dx.doi.org/10.25258/ijpqa.15.1.35.

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A rapid, sensitive and selective electrospray ionization liquid chromatography-mass spectrometry (LC-MS) approach was developed to find and quantify the two genotoxic RANO contaminants (A and G) and forced degradation products of RANO in formulations of pharmaceutical drugs. X Select CSH C18 (100 x 3.0 mm, 2.5 μm) instrument was utilized for the separation with mobile phase containing of ammonia solution (A) and methanol (B) in gradient elution. About 254 nm as detection wavelength and 0.3 mL/min as flow rate were maintained. RANO has been degraded under stress conditions like thermal, oxidati

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Al‐Sabti, Bashar, and Jehad Harbali. "Development and validation of an analytical method for quantitative determination of three potentially genotoxic impurities in vildagliptin drug material using HPLC‐MS." Journal of Separation Science 44, no. 13 (2021): 2587–95. http://dx.doi.org/10.1002/jssc.202100136.

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Grigori, Katerina, Yannis L. Loukas, Anđelija Malenović, et al. "Chemometrically assisted development and validation of LC–MS/MS method for the analysis of potential genotoxic impurities in meropenem active pharmaceutical ingredient." Journal of Pharmaceutical and Biomedical Analysis 145 (October 2017): 307–14. http://dx.doi.org/10.1016/j.jpba.2017.06.061.

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. Venkateswarlu, V., K. Hussain Reddy, and G. . Ramireddy. "DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS BY LC-MS/MS FOR THE DETERMINATION OF PROCESS RELATED GENOTOXIC IMPURITIES IN LANSOPRAZOLE." Rasayan Journal of Chemistry 12, no. 03 (2019): 1584–90. http://dx.doi.org/10.31788/rjc.2019.1235210.

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Tsanaktsidou, Eleni, Lamprini Kanata, Sofia Almpani, Constantinos K. Zacharis, and Catherine K. Markopoulou. "Development and Validation of an HPLC-FLD Method for the Determination of NDMA and NDEA Nitrosamines in Lisinopril Using Pre-Column Denitrosation and Derivatization Procedure." Separations 9, no. 11 (2022): 347. http://dx.doi.org/10.3390/separations9110347.

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In order to meet the analytical requirements of the European Medicines Agency (EMA), a new HPLC-FLD method was successfully developed using dansyl chloride for the derivatization and determination of the genotoxic impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in Lisinopril API and its final product. Samples’ pretreatment includes liquid–liquid microextraction, denitrosation, and derivatization steps. To optimize the process, the parameters contributing to high sensitivity and yielding reliable results were thoroughly studied and optimized using one-factor-at-a-time

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Liu, Zhen, Huajun Fan, Yihui Zhou, et al. "Development and validation of a sensitive method for alkyl sulfonate genotoxic impurities determination in drug substances using gas chromatography coupled to triple quadrupole mass spectrometry." Journal of Pharmaceutical and Biomedical Analysis 168 (May 2019): 23–29. http://dx.doi.org/10.1016/j.jpba.2018.12.044.

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Subbaiah, Nelaturi, Gopireddy Venkata Subba Reddy, Nitesh Kanyawar, Manish Gangrade, and J. Jayachandran. "A Selective and Sensitive Method Development and Validation by LC-MS/MS Approach for Trace Level Quantification of Two Potential Genotoxic Impurities in Albendazole Drug Substance." Journal of Chemical and Pharmaceutical Sciences 11, S01 (2018): 33–36. http://dx.doi.org/10.30558/jchps.201811s01007.

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Rajana, Nagaraju, D. V. Ramana, Rama Rao Ganta, et al. "An orthogonal approach for method development and validation of three potential halo alkyl alcohol genotoxic impurities in miglitol drug substance by fast gas chromatography–mass spectrometry." SEPARATION SCIENCE PLUS 3, no. 10 (2020): 511–22. http://dx.doi.org/10.1002/sscp.202000050.

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Konduru, Naresh, Rambabu Gundla, Naresh Kumar Katari, Kalyani Paidikondala, Annem Siva Reddy, and Varaprasad Jagadabi. "Development and Validation of a Stability-indicating Method for Ibrutinib: Identification and Separation of Degradation Products, Known and Genotoxic Impurities Using RP-HPLC/PDA and QDa Mass Detectors." Analytical Chemistry Letters 10, no. 1 (2020): 113–36. http://dx.doi.org/10.1080/22297928.2019.1673814.

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Pepakayala, Sriram, Venkata Nadh Ratnakaram, Yuvaraj Zunjarrao, and Yogesh Kumar Lohia. "Determination of potential genotoxic NDSRIs (Nitrosamine Drug Substance Related Impurities) in Quetiapine Fumarate – antipsychotic medication: (Q)SAR assessment, UPLC-ESI-MS/MS method development, validation and its analytical greenness evaluation." Sustainable Chemistry and Pharmacy 45 (June 2025): 102032. https://doi.org/10.1016/j.scp.2025.102032.

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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 Impurities of ERL Ethyl Ester and ERL Nitro Compound in Erlotinib Hydrochloride Drug Substance." Oriental Journal of Chemistry 33, no. 3 (2017): 1575–80. http://dx.doi.org/10.13005/ojc/330364.

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Anerao, Ajit, Vishal Solase, Thaksen Gadhave, Amol More, and Nitin Pradhan. "Quantification of Genotoxic Impurities in Key Starting Material of Sertraline Hydrochloride by Simple and Sensitive Liquid Chromatography Technique." Current Pharmaceutical Analysis 16, no. 1 (2019): 110–16. http://dx.doi.org/10.2174/1573412914666180716160507.

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Background: Schiff base is an advanced key starting material of Sertraline hydrochloride. Schiff base is synthesized using two raw materials 1-Naphthol and 1,2-Dichlorobenzene which are potentially genotoxic impurities. Objective: Genotoxic impurities need to be controlled in key starting material to avoid carry forward in the active pharmaceutical ingredient. For trace level quantification of impurities a sensitive, accurate and cost effective method is developed by simultaneous estimation of both impurities. Methods: Reverse phase high performance liquid chromatography (HPLC) method was deve

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Puppala, Ravi Kumar, Nelaturi Subbaiah, and K. Sesha Maheswaramma. "CHARACTERISATION AND EVALUATION OF THE TRACE LEVEL OF GENOTOXIC IMPURITIES IN BICTEGRAVIR SODIUM DRUG SUBSTANCE BY USING LIQUID CHROMATOGRAPHY-MASS SPECTROSCOPY." RASAYAN Journal of Chemistry 15, no. 03 (2022): 2059–64. http://dx.doi.org/10.31788/rjc.2022.1536966.

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A selective and sensitive novel method was established and validated for well-characterized tert-butyl ((1S, 3R)-3- acetylcyclopentyl) Carbamate (Acetyl BOC) and tert-butyl (1S, 3R)-3-hydroxycyclopentyl) Carbamate (Hydroxy BOC) genotoxic impurities in Bictegravir sodium active pharmaceutical ingredient by using liquid chromatographytandem mass spectrometry. The developed method was more accurate and capable to confirm the m/z values of parent and fragment ions, method was validated through ICH guidelines to detect 0.3 ppm and estimate up to 1.0 ppm of both impurities. The correlation coefficie

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Li, Jiaxin, Eyoro Noah Nadine Joelle, Qian Yang, Feng Zheng, Wenyuan Liu, and Jing Liu. "Determination of residual phenylhydrazines in drug substances by high-performance liquid chromatography with pre-column derivatization." Analytical Methods 11, no. 48 (2019): 6146–52. http://dx.doi.org/10.1039/c9ay02231g.

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Antolčić, Mia, Mislav Runje, and Nives Galić. "A simple and sensitive LC-MS/MS method for determination and quantification of potential genotoxic impurities in the ceritinib active pharmaceutical ingredient." Analytical Methods 12, no. 25 (2020): 3290–95. http://dx.doi.org/10.1039/d0ay00511h.

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Nanduri, V. V. S. S. R., A. V. S. S. Prasad, and K. R. Reddy. "SENSITIVE LIQUID CHROMATOGRAPHIC METHODS FOR THE DETERMINATION OF GENOTOXIC IMPURITIES IN LETROZOLE." INDIAN DRUGS 52, no. 03 (2015): 24–27. http://dx.doi.org/10.53879/id.52.03.p0024.

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Sensitive liquid chromatographic methods for the determination of two genotoxic impurities, namely hydrazine hydrate and 4-bromomethyl benzonitrile, in letrozole have been presented. Method-A is the pre-column derivative UFLC method for the determination of hydrazine hydrate with 4-methoxy benzaldehyde in letrozole. The chemistry involved in the derivatization is explained with suitable mechanism. Method-B offers the determination of 4-bromomethyl benzonitrile in letrozole. Both the methods were validated as per International Conference on Harmonization guidelines. Correlation coefficient valu

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Wang, Yue, Jing Feng, Song Wu, et al. "Determination of Methyl Methanesulfonate and Ethyl Methylsulfonate in New Drug for the Treatment of Fatty Liver Using Derivatization Followed by High-Performance Liquid Chromatography with Ultraviolet Detection." Molecules 27, no. 6 (2022): 1950. http://dx.doi.org/10.3390/molecules27061950.

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A new derivatization high-performance liquid chromatography method with ultraviolet detection was developed and validated for the quantitative analysis of methanesulfonate genotoxic impurities in an innovative drug for the treatment of non-alcoholic fatty liver disease. In this study, sodium dibenzyldithiocarbamate was used as a derivatization reagent for the first time to enhance the sensitivity of the analysis, and NaOH aqueous solution was chosen as a pH regulator to avoid the interference of the drug matrix. Several key experimental parameters of the derivatization reaction were investigat

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Al-Sabti, Bashar, and Jehad Harbali. "HPLC–MS Analysis of Four Potential Genotoxic Impurities in Alogliptin Pharmaceutical Materials." Journal of AOAC INTERNATIONAL 105, no. 2 (2021): 362–69. http://dx.doi.org/10.1093/jaoacint/qsab152.

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Abstract Background Pyridine, 3-aminopyridine, 4-dimethylaminopyridine, and N, N-dimethylamine are reactive bases that may be used in the preparation of the pharmaceutical ingredient alogliptin (ALO). They are considered as potentially genotoxic impurities (PGIs) since they contain electrophilic functional groups. Therefore, they should be monitored at the allowed limits in ALO. Objective The aim of this study was to develop a novel liquid chromatography–mass spectrometry (LC–MS) method to estimate quantities of pyridine, 3-aminopyridine, 4-dimethylaminopyridine, and N, N-dimethylaniline impur

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Sun, Mingjiang, David Q. Liu, and Alireza S. Kord. "A Systematic Method Development Strategy for Determination of Pharmaceutical Genotoxic Impurities." Organic Process Research & Development 14, no. 4 (2010): 977–85. http://dx.doi.org/10.1021/op100089p.

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

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

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Sojitra, C., S. Agarwal, C. Dholakia, P. Sudhakar, and K. K. Singh. "QUANTIFICATION OF HYDRAZINE HYDRATE IN IMATINIB MESYLATE AT GENOTOXIC LEVEL BY CHROMATOGRAPHIC METHOD." INDIAN DRUGS 56, no. 12 (2019): 45–52. http://dx.doi.org/10.53879/id.56.12.11971.

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Hydrazine hydrate has genotoxic effect in nature and so it should be controlled down as Potential Genotoxic Impurity (PGI). Being polar molecule, hydrazine hydrate (N2H4.H2O) has no chromophores present in structure which can follow Lambert beer law, thus it is difficult to analyze. The present work described an accurate and highly sensitive reversed-phase liquid chromatography-UV derivatization method for determination of hydrazine in imatinib mesylate drug substance. The method of quantification was developed by attaching chromophores to hydrazine with derivatization, which helped to increas

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Kakadiya, P. R., T. G. Chandrashekhar, S. Ganguly, D. K. Singh, and V. Singh. "Low Level Determinations of Methyl Methanesulfonate and Ethyl Methanesulfonate Impurities in Emtricitabine Active Pharmaceutical Ingredient by LC/MS/MS using Electrospray Ionization." Analytical Chemistry Insights 6 (January 2011): ACI.S6471. http://dx.doi.org/10.4137/aci.s6471.

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Alkyl methanesulfonates have been highlighted as potential genotoxic impurities (PGIs). A sensitive LC/MS/MS method was developed and validated for the determination of Alkyl methanesulfonate impurities in Emtricitabine API (active pharmaceutical ingredient). LC/MS/MS method on Zorbax SB C18 column (150 × 4.6 mm i.d.), 3.5 μm, with electrospray ionization (ESI) in multiple reaction monitoring (MRM) mode was used. The proposed method was specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.0025 μg/ml to 0.3 μg/ml the corr

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Retracted. "Retracted: Risk Assessment of Genotoxic Impurities in Drug Substances." International Journal of Mathematics and Physical Sciences Research 10, no. 1 (2022): 6–13. https://doi.org/10.5281/zenodo.6572606.

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<strong>Retraction Notice</strong>Title of paper: Risk Assessment of Genotoxic Impurities in Drug SubstancesAuthor Name: Santosh Kumar Amarbahadur SinghRetraction Reason: Publishing terms violation (Plagiarism found in Paper)Date of Retraction: 1 April 2024Other details of paper: International Journal of Mathematics and Physical Sciences Research ISSN 2348-5736 (Online), Vol. 10, Issue 1, pp: (6-13), Month: April 2022 - September 2022

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Pawanpreet, Kaur* and Baljeet Singh. "ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE: A REVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 06 (2018): 5065–70. https://doi.org/10.5281/zenodo.1286729.

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Analytical method development and validation is an integral part during the development of drug substance and drug product in the pharmaceutical industry. It plays important role in the discovery, development, manufacture and quality control of pharmaceuticals. Analytical methods are designed to determine the drug content in formulation, presence of impurities, separation of drug and its related impurities and degraded products. Validation of method proves that it can be suitable for its use in research and development and assures the reliability of proposed method. Now days, need of analytica

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Vadivelu, Anantha Lakshmi, Sathapathy Panduranga Vittal, and Duvvuri Suryakala. "UHPLC Specific Method for Simultaneous Determination of Probable Impurities of Ezetimibeand Simvastatin in Combined Dosage Form." Oriental Journal Of Chemistry 40, no. 1 (2024): 228–38. http://dx.doi.org/10.13005/ojc/400128.

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Method development, degradation impurities that may appear in Ezetimibe, Simvastatin tablets with Ultra High Performance Liquid Chromatography (UHPLC or UPLC) technique. Water’s Acquity High strength (HSS) T31.8µ, 100x 2.1mm column is used for critical separation between closely eluting impurities originating from the combined dosage form. Perchloric acid buffer (1.0 mL/L)and acetonitrile are selected as Elution phase A, B. The resolution between polar, mid polar and highly polar impurities is achieved with flow of 0.5 mL per minute in step gradient mode with short run time. Detection was done

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Gandhi, V. Garamsandh, Gokul M. Gokul.M, Pragatheswaran S. Pragatheswaran.S, et al. "Method Development Validation and Estimation of Impurities in Dicyclomine Hydrochloride Capsule by RP HPLC." International Journal of Pharmaceutical Research and Applications 10, no. 1 (2025): 1567–88. https://doi.org/10.35629/4494-100115671588.

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This study's objective was to Developed and validated a new Reverse Phase- High-Performance Liquid Chromatography (RP-HPLC) method for the determination of Impurities in Dicyclomine HCl capsules. The method was developed by adapting the USP API monograph and checked for feasibility study and applied to capsule formulation, In this API methods methods not suitable for estimation of impurities in capsule formulation, hence study was made in changing the column for Known impurity, diluent composition, pH of the mobile phase, Flow rate change and different mobile phases for unknown impurities. By

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