高效液相色谱法测定复方替硝唑栓剂中两组分的含量

目的 建立高效液相色谱法分离并测定复方替硝唑栓剂中两组分的含量，为该制剂制订质量标准提供科学依据。方法 采用Symmetry C18柱（2．5cm×4．6mm，5μm），流动相为甲醇：水：磷酸（65：35：0．1），pH值=3．65，检测波长为282nm，流速为1．0ml／min。结果 替硝唑、克霉唑的浓度线性范围分别为41．50～207．50μg·ml^-1；21．22—106．10μg·ml^-1。平均回收率分别为97．63％、98．02％，RSD分别为0．85％、1．09％；结论 方法简便，结果准确，重现性好，可用于该制剂的质量控制。

Determination of Two Components in Compound Tinidazole Suppositories by HPLC

Aim To establish an HPLC （high performance liquid chromatography） method for determination of two components in compound Tinidazole suppositories and provide scientific data on this preparation for the making of quality specifications. Methods A Symnetry-C18 column （2.5cm × 4.6mm,5μm） was used, and the mobile phase was the mixture of Colonial spirit-Water-Phosphoric acid （65： 35： 0.1 ）, pH value = 3.65 ; the UV detector was operated at 282nm, and the flow rate was 1.0ml/min. Results The linear ranges of Tinidazole and Clotrimazole were 41.50 - 207.50μg·m^-1and 21.22 - 106.10μg·ml^-1 ;the average recovery was 97.63% and RSD =0. 85% （n = 5 ）. Conclusion This method can be used in this preparations quality control, characterized by simple operation, accurate results and good reproducibility.