HPLC法测定洛伐他汀分散片的含量及含量均匀度

Determination of Content and Content Uniformity of Lovastatin Dispersible Tablet by HPLC

目的：建立测定洛伐他汀分散片含量及含量均匀度的方法,为其仿制生产和贮存期质量控制提供参考。方法：采用高效液相色谱法。色谱柱为Waters MS C18,流动相为乙腈-0.01%磷酸（55∶45,V/V）,检测波长为238 nm,柱温为30℃,流速为1.0 ml/min,进样量为20μl。结果：洛伐他汀检测质量浓度线性范围为20.32-609.60μg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;回收率为99.60%-101.68%,RSD=0.8%（n=9）。结论：该方法的重复性好、准确度高,适于洛伐他汀分散片的质量控制。

OBJECTIVE：To establish a method for the determination of content and content uniformity in Lovastatin dispersible tablet,to provide reference for the quality control of its peneric production and storage period. METHODS：HPLC method was adopted on the column of Waters MS C_（18） with mobile phase of acetonitrile-0.01% phosphoric acid（55 ∶ 45,V/V）,detection wavelength was 238 nm,column temperature was 30 ℃,flow rate was 1.0 ml/min,and the volume injection was 20 μl. RESULTS：The linear range of lovastatin was 20.32-609.60 μg/ml（r=0.999 9）;RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.60%-101.68%（RSD=0.8%,n=9）. CONCLUSIONS：The method is reproducible with high accuracy,and suitable for the quality control of Lovastatin dispersible tablet.