脂必泰胶囊中红曲的含量测定

Determination of Lovastatin in Zhibitai Capsules by HPLC

目的建立测定脂必泰胶囊红曲中洛伐他汀含量的高效液相色谱法。方法色谱柱为Dionex C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(75∶25),流速为1 mL/min,柱温为22℃,检测波长为236 nm,进样量为10μL。样品以75%乙醇超声提取10 min后进样测定,定量方法采用峰面积外标法。结果洛伐他汀质量浓度在0.011 83～0.473 2 g/L范围内与峰面积积分值线性关系良好(r=0.999 9),方法平均回收率为99.07%,RSD=1.77%(n=6)。结论该方法简单、快速、准确,适用于测定脂必泰胶囊红曲中洛伐他汀的含量。

Objective To establish an HPLC method for the determination of lovastatin in Zhibitai Capsules.Methods A Dionex C18 column（250 mm×4.6 mm,5 μm）was used.The mobile phase was methanol-water（75 ∶25）with 1.0 mL/min of flow rate,the detective wavelength was 236 nm.External standard method was used.Results The standard curve of lovastatin was linear in the concentration of 0.011 83-0.473 2 g/L（r=0.999 9）,the average recovery rate was 99.07%,RSD=1.77%（n=6）.Conclusion The HPLC method was simple,rapid and accurate for the determination of lovastatin in Zhibitai Capsules.