Development and validation of a stability-indicating RP-HPLC method for the determination of fifteen impurities in rivaroxaban

被引：6

作者：

Rao, Wanbing ^{[1
,2
]}

Li, Lijun ^{[1
,2
]}

Zhang, Chenxia ^{[1
,2
]}

Zheng, Jinfu ^{[1
,2
]}

Fan, Xiaomei ^{[1
,2
]}

Luan, Baolei ^{[1
,2
]}

Sun, Jiaxiang ^{[1
,2
]}

Qiu, Meiyan ^{[1
,2
]}

Wu, Shuming ^{[1
,2
]}

Li, Yanhua ^{[1
,2
]}

Wang, Zhongqing ^{[1
,2
]}

机构：

[1] HEC Pharm Grp, HEC Res & Dev Ctr, Dongguan 523871, Peoples R China

[2] Sunshine Lake Pharm Co Ltd, State Key Lab Antiinfect Drug Dev, Dongguan 523871, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2023年 / 228卷

关键词：

Rivaroxaban; Analytical method development; Validation; Related impurities; Characterization; European pharmacopoeia (EP); DEGRADATION-PRODUCTS;

D O I：

10.1016/j.jpba.2023.115325

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A simple and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method for the determination of rivaroxaban (RIX) and its related substances was developed. Fifteen impurities of RIX, including three unreported isomers, were identified, synthesized, purified, and confirmed using MS, 1H NMR, 13C NMR, and HSQC spectral methods. This new method offered baseline separation for all monitored impurities, and was fast and reliable when compared to the European Pharmacopoeia method. Optimum separation for RIX and its related impurities was achieved on an octyldecyl silica column (YMC Core C18, 4.6 x100 mm, 2.7 mu m) by using a gradient HPLC method in 38 min. The final method was validated with respect to precision, LOD and LOQ, linearity, accuracy, and robustness. This developed method was suitable for routine quality control and drug analysis of RIX active substance.

引用

页数：10

共 19 条

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