RP-HPLC测定洛伐他汀及片剂的有关物质

RP-HPLC Determination of the Related Substances of Lovastatin and Its Tablets

目的建立洛伐他汀及片剂有关物质的HPLC测定方法,同时考察了13批洛伐他汀原料及12批洛伐他汀片剂的有关物质。方法使用Xterra C18柱(4.6mm×250mm,5μm),以乙腈-0.01%磷酸(60∶40)为流动相采用线性梯度表洗脱,流速为1.0mL·min-1,检测波长为238nm。结果洛伐他汀色谱保留时间约为15min,与其有关物质分离良好,洛伐他汀的检测限为0.25ng。结论方法准确、灵敏度高,本方法可有效地控制药品质量。

OBJECTIVE To establish a method for determination of the related substances of lovastatin and its tablets by HPLC.And to inspect the related substances of thirteen batches of lovastatin and twelve batches of lovastatin tablets.METHODS An Xterra C18 column(4.6 mm×250 mm,5 μm)was used.The mobile phase was acetonitrile-0.01% phosphoric acid(60∶40,the method was linear elution),the speed was 1.0 mL·min-1,and the wavelength of UV detector was 238 nm.RESULTS The retention time was about 15 min,and the resolution of lovastatin with its related compounds was good.The limit of quantitation was 0.25 ng.CONCLUSION The method was convenient and accurate.As the same time,the method can intendance and control the related substance in production.