HPLC测定克霉唑溶液的含量及有关物质

Determination of the contents and related substances in Clotrimazole solution by HPLC

目的采用HPLC法测定克霉唑溶液的含量及其有关物质。方法Waters C18(150mm×4.6mm,5μm)色谱柱,流动相为甲醇-0.05mol·L-1磷酸二氢钾溶液(7∶3,稀磷酸调pH5.75),流速1.5mL·min-1,检测波长215nm。结果克霉唑10.62～106.20μg·mL-1与峰面积线性关系良好(r=0.9999),平均回收率为99.8%,RSD=0.7%(n=9)。有关物质二苯基-(2-氯苯基)甲醇0.2548～10.1900μg·mL-1与峰面积线性关系良好(r=0.9999),平均回收率为100.19%,RSD=0.96%(n=9),限度为不得大于克霉唑标示量的2.0%。结论所建方法准确、简便、快速,适用于克霉唑的含量测定和有关物质的检查。

OBJECTIVE To establish an HPLC method for determination of the contents and related substances in Clotrimazole solution.METHODS Waters C18 column was used(150 mm × 4.6 mm,5 μm) with UV detection at 215 nm,and the mobile phase consisted of methanol and 0.05 mol·L -1 potassium dihydrogen phosphate(7∶3,adjusted to pH5.75 with phosphoric acid).The flow rate was 1.5 mL·min -1.RESULTS The calibration curve was linear(r = 0.9999)within the range of 10.62-106.20 μg·mL -1for Clotrimazole .The average recovery was 99...