高效液相色谱法测定西立伐他汀钠片剂中西立伐他汀及有关物质含量

HPLC Determination of Cerivastatin and Its Related Substances in Cerivastatin Sodium Tablets

目的 :建立一种高效液相色谱法测定西立伐他汀钠片剂中西立伐他汀及其有关物质含量的方法。方法 :用C18柱 ,以甲醇 -磷酸二氢钾缓冲液 (磷酸二氢钾 1g→ 10 0 0mL ,用磷酸调节 pH 2 5 ) (87∶13)为流动相 ,检测波长为 2 83nm ,流速 1 0mL·min-1,柱温 45℃。结果 :主成分与其它 4个杂质峰在 10min内完全分离 ,西立伐他汀钠在 2 5～ 5 0 μg·mL-1浓度范围内呈良好的线性关系 ,3种规格片剂的平均回收率在 99 3%～ 10 0 2 %范围内。结论 :该方法专属性好 ,每片 0 1,0 2 ,0 3mg的 3种规格样品的实验精密度RSD分别为 0 6 2 % ,0 5 3 % ,0 6 1% 。

Objective:To develop HPLC method for the determination of cerivastatin and its related substances in cerivastatin sodium tablets.Methods:The separation was performed on a Nucleosil 120-5 C\-\{18\} column with methanol-phosphate buffer(87∶13,adjust pH to pH 2 5 with H\-3PO\-4) as the mobile phase.The flow rate was 1 0 mL·min\+\{-1\}, the detection was set at 283 nm and the column temperature was maintained at 45 ℃.Results:Cerivastatin was completely separated from other 4 impurities within 10 min.The calibration curve was linear in the range of 2 5～50 μg·mL\+\{-1\},the average recovery was within the range of 99 3%～100 2% for the three dosage tablets( n =6).The method was proved to be accurate and repeatable.Conclusion:The proposed HPLC method could be used for the determination of cerivastatin and its related substances in cerivastatin sodium tablets.