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目的采用HPLC测定洛伐他汀及其胶囊的含量。方法色谱柱为Agela C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.01%磷酸(60:40),流速1.0 m.lmin-1,检测波长238 nm。结果洛伐他汀的线性方程为:A=5.980×104+2.910×104C(r=0.9999),线性范围4.88~305.00μg.ml-1,胶囊平均回收率为100.20%,RSD=0.24%(n=9)。结论所建方法准确、重复性好、操作简单,可有效地控制药品质量。
Objective To determine the content of lovastatin and its capsule by HPLC. Methods The column was an Agela C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-0.01% phosphoric acid (60:40) at a flow rate of 1.0 m · lmin-1 and a detection wavelength of 238 nm. Results The linear equation of lovastatin was as follows: A = 5.980 × 104 + 2.910 × 104C (r = 0.9999), the linear range was 4.88 ~ 305.00μg.ml-1, the average recovery was 100.20% and the RSD was 0.24% 9). Conclusion The method is accurate, reproducible and easy to operate, which can effectively control the quality of medicines.