RP-HPLC测定环孢菌素A凝胶剂中环孢菌素A的含量

Determination of the content of the cyclosporine A in the cyclosporine A gel by the reversed-phase HPLC

目的测定环孢菌素A凝胶剂中环孢菌素A的含量。方法反相高效液相色谱法 ,采用Kro masilC8色谱柱 ,甲醇∶水 (90∶10 ,V∶V)为流动相 ,2 14nm为检测波长 ,在室温条件下对环孢菌素A凝胶剂进行含量测定。结果环孢菌素A与其他组分能较好的分离 ,在 1 4 14～ 7 2 34μmol/L内 ,环孢菌素A峰面积与浓度呈良好的线性关系 (r =0 9999) ;样品平均回收率为 99 98% (RSD =1 1% )。

Objective To develop a RP HPLC method to determine the content of cyclosporine A in the cyclosporine A gel. Methods The kromasil C 8 column was used.The mobile phase consisted of methanol and water (90∶10, V∶V) ,the peaks were detected at 214 nm .The column temperature was the room temperature.Results Cyclosporine A could be isolated from other components.The calibration curves were liner in the range of 1 414 μmol/L ～ 7 234 μmol/L ( r =0 999 9 ) for CsA. The average recovery was 99 98% with RSD=1 1% ( n =5). Conclusions The method can evaluate well and the true quality of the Cyclosporine A gel.