高效液相色谱法测定环孢素A含量

HPLC Determination of Cyclosporine A

提出了高效液相色谱法测定环孢素A含量的方法。以Agilent Extend C18色谱柱(250mm×4.6mm,5μm)为固定相,以乙腈、水、叔丁基甲醚和磷酸按体积比500比500比50比1的混合溶液为流动相,用紫外检测器检测,检测波长为210nm。环孢素A的质量浓度在0.025～2.00g.L-1范围内与其峰面积呈线性关系。方法应用于环孢素原料药分析,测定结果的相对标准偏差(n=6)小于1.0%,用标准加入法做回收试验,回收率在99.3%～101%之间。

A method of determination of cyclosporine A by HPLC was proposed. Agilent Extend C18 （250mm×4.6mm,5μm） was used as stationary phase, and a mixture of acetonitrile, water, tert butyl methyl ether and phosphoric acid （mixed in the ratio of 500 to 500 to 50 to 1） was used as mobile phase. UV detection at 210 nm was adopted in the determination. Linear relationship between values of peak area and mass concentration of cyclosporine A was kept in the range of 0. 025-2.00 g·L-1. The proposed method was used in the analysis of raw medicine of eyclosporine, values of recovery found by standard addition method were in range of 99. 3%--101% with RSD （n=6） less than 1.0%.