论文部分内容阅读
目的建立用反相高效液相色谱法测定辛伐他汀胶囊有关物质的方法,同时考察了19批辛伐他汀胶囊的有关物质。方法使用SUPELCO C18色谱柱(4.6 mm×33 mm,3μm),以乙腈-0.1%磷酸溶液(50∶50)为流动相A,0.1%磷酸的乙腈溶液为流动相B,梯度洗脱。检测波长为238 nm,流速为3.0 mL.min-1。结果辛伐他汀峰与洛伐他汀峰及其余有关物质分离良好,辛伐他汀的检测限为0.25 ng。结论方法准确、灵敏度高,可作为该制剂的质量控制方法。
OBJECTIVE To establish a method for the determination of simvastatin capsules by reversed-phase high performance liquid chromatography (RP-HPLC) and to investigate the related substances of simvastatin capsules in 19 batches. Methods The mobile phase B was eluted with SUPELCO C18 column (4.6 mm × 33 mm, 3 μm) using acetonitrile-0.1% phosphoric acid solution (50:50) as mobile phase A and 0.1% phosphoric acid in acetonitrile as mobile phase B. The detection wavelength was 238 nm and the flow rate was 3.0 mL.min-1. Results The peak of simvastatin was separated from lovastatin peak and other related substances. The detection limit of simvastatin was 0.25 ng. Conclusion The method is accurate and sensitive and can be used as a quality control method for this preparation.