RP-HPLC测定辛伐他汀胶囊的有关物质

RP-HPLC Determination of the Related Substances of Simvastatin Capsules

关键词:  辛伐他汀胶囊  有关物质  梯度洗脱法  反相高效液相色谱法

Key words:  simvastatin capsule  relative substances  gradient elution  RP-HPLC

摘要:

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，3 μm)，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。

Abstract:

OBJECTIVE To establish a method for determination of the related substances of simvastatin capsules by RP-HPLC gradient elution method. And the related substances of nineteen batches of simvastatin capsules are detected. METHODS A SUPELCO C₁₈column(4.6 mm×33 mm, 3 μm)was used. The mobile phase A was acetonitrile-0.1% phosphoric acid (50∶50), mobile phase B composed of 0.1% phosphoric acid acetonitrile solution, with gradient elution method. The wavelength of UV detector was 238 nm, the flow rate was 3.0 mL·min^-1. RESULTS The resolutions of simvastatin and lovastatin and other related substances were good. The limit of quantitation was 0.25 ng. CONCLUSION The method is accurate and repeatable, and could be applied to control the quality of this drug.