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目的建立RP-HPLC-UV法用于盐酸雷诺嗪的含量和有关物质测定。方法采用Waters XBRIDGE C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-20 mmol·L-1磷酸二氢钾溶液(用三乙胺调节pH值至7.0)(体积比40∶60),流速为1.0 mL·min-1,检测波长为215 nm,进样量为10μL。结果盐酸雷诺嗪质量浓度在9.068~226.7 mg·L-1内线性关系良好(r=0.999 6),重复性试验RSD为0.96%,主峰与各杂质均具有较好的分离度。结论该方法快速、准确、专属性强,适用于盐酸雷诺嗪及其制剂的质量控制。
Objective To establish a RP-HPLC-UV method for the determination of ranolazine hydrochloride and related substances. Methods Waters XBRIDGE C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-20 mmol·L-1 potassium dihydrogen phosphate solution (adjusted to pH 7.0 with triethylamine) (40:60 ), The flow rate was 1.0 mL · min-1, the detection wavelength was 215 nm, and the injection volume was 10 μL. Results The linear range of ranolazine concentration was 9.068 ~ 226.7 mg · L-1 (r = 0.999 6). The RSD of repeatability test was 0.96%. The main peak and impurities were well resolved. Conclusion The method is rapid, accurate and specific. It is suitable for the quality control of ranolazine hydrochloride and its preparation.