{"title":"HPTLC method for simultaneous determination of rivaroxaban and its aminomethyl process impurity/metabolite","authors":"Amit Shimpi, Bhatu Patil, Kunal Bhadane, Yogesh Agrawal, Vaishnavi Pawar, Amod Patil, Atul Shirkhedkar, Iqrar Ahmad, Harun Patel","doi":"10.1007/s00769-025-01663-9","DOIUrl":null,"url":null,"abstract":"<div><p>Simultaneous high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of rivaroxaban and its aminomethyl process impurity/metabolite. Using a toluene–methanol–triethylamine (6:3.5:0.5%v/v/v) mobile phase, the method achieved optimized R<i>f</i> values of 0.75 for rivaroxaban and 0.38 for the impurity. The method exhibited a linear response for both analytes in the range of 800–1300 ng/band, with correlation coefficients of 0.998 and 0.997, respectively. Sensitivity assessments revealed detection limits of 0.0086 ng/band for rivaroxaban and 0.0165 ng/band for the impurity, with quantification limits of 0.026 ng/band and 0.050 ng/band, respectively. Robustness and precision tests confirmed the method’s reliability, with %RSD values below 2.0 for all parameters. This validated HPTLC method offers an efficient solution for simultaneous determination of rivaroxaban and aminomethyl impurity/metabolite of rivaroxaban in pharmaceutical formulations. This simple HPTLC method provides a comprehensive approach for impurity profiling and quality control in pharmaceutical formulations. Its high sensitivity, reproducibility, and robustness make it a valuable tool in ensuring drug safety and compliance with regulatory standards.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"419 - 427"},"PeriodicalIF":1.0000,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accreditation and Quality Assurance","FirstCategoryId":"5","ListUrlMain":"https://link.springer.com/article/10.1007/s00769-025-01663-9","RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0
Abstract
Simultaneous high-performance thin-layer chromatography (HPTLC) method was developed and validated for the quantification of rivaroxaban and its aminomethyl process impurity/metabolite. Using a toluene–methanol–triethylamine (6:3.5:0.5%v/v/v) mobile phase, the method achieved optimized Rf values of 0.75 for rivaroxaban and 0.38 for the impurity. The method exhibited a linear response for both analytes in the range of 800–1300 ng/band, with correlation coefficients of 0.998 and 0.997, respectively. Sensitivity assessments revealed detection limits of 0.0086 ng/band for rivaroxaban and 0.0165 ng/band for the impurity, with quantification limits of 0.026 ng/band and 0.050 ng/band, respectively. Robustness and precision tests confirmed the method’s reliability, with %RSD values below 2.0 for all parameters. This validated HPTLC method offers an efficient solution for simultaneous determination of rivaroxaban and aminomethyl impurity/metabolite of rivaroxaban in pharmaceutical formulations. This simple HPTLC method provides a comprehensive approach for impurity profiling and quality control in pharmaceutical formulations. Its high sensitivity, reproducibility, and robustness make it a valuable tool in ensuring drug safety and compliance with regulatory standards.
期刊介绍:
Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.