HPLC测定克霉唑阴道片的主药及有关物质

Determination of the contents and related substances in Clotrimazole vaginal tablets by HPLC

目的建立测定克霉唑阴道片含量及其有关物质的方法。方法采用HPLC法,Luna C18色谱柱,甲醇-0.0125 mol.L-1磷酸氢二钠(78:22,磷酸调pH5.5)为流动相,检测波长220 nm。结果克霉唑2.5～40.0μg.ml-1与峰面积的线性关系良好(r=0.9999),平均回收率为99.5%～100.2%,RSD=0.1%(n=6)。有关物质咪唑为0.032%～0.037%,单一最大杂质为0.16%,有关物质总量为0.36%～0.37%。结论所建方法准确、简便、快速,适用于克霉唑阴道片的质量控制。

OBJECTIVE To establish an HPLC method for determination of the contents and related substances in Clotrimazole vaginal tablets. METHODS Luna C18 column was used （ 150 mm ×4. 6 mm, 5 μm） with UV detection at 220 nm, and the mobile phase consisted of methane - 0. 0125 mol · L^- 1 disodium hydrogen phosphate （78 ： 22, adjusted to pH5. 5 with phosphoric acid）. The flow rate was 1.0 ml·min^-1. RESULTS The calibration curve was linear （ r = 0. 9999 ） within the range of 2. 5 - 40. 0 μg·ml^ -1 for Clotrimazole . The average recovery was from 99. 51% to 100. 2% for three different levels of the amount of Clotrimazole vaginal tablets, RSD was 0, 10%, The imidazole in related substances was 0.032% - 0. 037%, the largest impurity was all 0. 16% and the related substances were 0. 36% -0. 37%. CONCLUSION This method is simple,rapid,accurate and effective for testing related substances in Clotrimazole vaginal tablets and for its content determination.