HPTLC method for simultaneous determination of rivaroxaban and its aminomethyl process impurity/metabolite

IF 1 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL
Amit Shimpi, Bhatu Patil, Kunal Bhadane, Yogesh Agrawal, Vaishnavi Pawar, Amod Patil, Atul Shirkhedkar, Iqrar Ahmad, Harun Patel
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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.

高效液相色谱法同时测定利伐沙班及其氨甲基工艺杂质/代谢物
建立了同时高效薄层色谱法(HPTLC)定量分析利伐沙班及其氨基甲基工艺杂质/代谢物的方法。采用甲苯-甲醇-三乙胺(6:3.5:0.5%v/v/v)流动相,利伐沙班的最佳Rf值为0.75,杂质的最佳Rf值为0.38。该方法在800 ~ 1300 ng/波段范围内具有良好的线性响应,相关系数分别为0.998和0.997。灵敏度评估显示,利伐沙班和杂质的检出限分别为0.0086 ng/带和0.0165 ng/带,定量限分别为0.026 ng/带和0.050 ng/带。鲁棒性和精密度试验证实了该方法的可靠性,所有参数的%RSD值均小于2.0。该方法为同时测定制剂中利伐沙班及利伐沙班胺甲基杂质/代谢物提供了一种有效的方法。这种简单的HPTLC方法为药品配方中的杂质分析和质量控制提供了全面的方法。它的高灵敏度、重复性和鲁棒性使其成为确保药物安全和符合监管标准的宝贵工具。
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来源期刊
Accreditation and Quality Assurance
Accreditation and Quality Assurance 工程技术-分析化学
CiteScore
1.80
自引率
22.20%
发文量
39
审稿时长
6-12 weeks
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.
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