HPLC法测定阿托伐他汀钙片的含量

目的建立高效液相色谱法测定阿托伐他汀钙片含量的方法。方法采用Agilent XDB-C18色谱柱(4.6 mm×250 mm,5μm),流动相为0.05 mol.L-1醋酸铵缓冲液(用冰醋酸调节pH值至5.0)-乙腈-四氢呋喃(53∶27∶20),检测波长为244 nm,柱温为35℃,流速为1.0 mL.min-1。结果阿托伐他汀浓度在19.98～139.89μg.mL-1范围内线性关系(r=0.999 96)良好,平均回收率为100.16%,RSD为0.06%。结论本方法专属强、准确度高,可用于阿托伐他汀钙片的质量控制。

Determination of Atorvastatin Calcium Tablets by HPLC

Objective To establish an HPLC method for the determination of Atorvastatin Calcium Tablets.Methods A stable HPLC method was established,and the chromatography was accomplished on an Agilent XDB-C18 column(4.6 mm × 250 mm,5 μm),the mobile phase consisted of 0.05 mol.L-1 of ammonium acetate in water(adjust with glacial acetic acid to pH 5.0)-acetonitrile-tetrahydrofuran(53∶ 27∶ 20),the detection wavelength was 244 nm,the column temperature was 35 ℃,the flow rate was 1.0 mL.min-1.Results The calibration curve was linear in the range of 19.98 ～ 139.89 μg.mL-1(r =0.999 96),the average recovery was 100.16% with corresponding RSD of 0.06%.Conclusion The method had strong property and high accuracy,it can be used for the quality control of Atorvastatin Calcium Tablets.