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目的:建立洛伐他汀胶囊有关物质的HPLC测定方法,并同时考察了全国数批洛伐他汀胶囊的有关物质。方法:使用C_(18)柱,以乙腈-0.01%磷酸溶液(60:40)为流动相采用线性梯度洗脱,检测波长为238nm。结果:洛伐他汀胶囊中主峰及其有关物质色谱峰保留时间适宜,分离良好。洛伐他汀的检测限为0.25ng。结论:方法准确、灵敏度高,可有效地控制药品质量。
OBJECTIVE: To establish a method for the determination of related substances of lovastatin capsules and to investigate the related substances of several lovastatin capsules in the country at the same time. Methods: The mobile phase consisted of C_ (18) column and acetonitrile - 0.01% phosphoric acid solution (60:40) with linear gradient. The detection wavelength was 238 nm. Results: Lovastatin capsules in the main peak and related substances peak retention time appropriate, well-separated. The detection limit of lovastatin is 0.25ng. Conclusion: The method is accurate, sensitive and can effectively control the quality of medicines.