反相高效液相色谱法测定克霉唑阴道片中克霉唑的含量

Determination of Clotrimazole in Clotrimazole Virgin Tablets by RP-HPLC

目的建立克霉唑阴道片中克霉唑含量的测定方法。方法采用高效液相色谱法,以HYPERSIL ODS C18柱（Φ4.6 mm×250.0 mm）,粒度5μm为分析柱,磷酸氢二钾溶液（取磷酸氢二钾4.35 g,加水溶解并稀释至1 000 ml）-甲醇（1：3）为流动相,流速为1.0 ml/min,检测波长为254 nm。结果克霉唑在0.1-5.0μg/ml范围内具有良好的线性关系。r=0.9999,平均回收率为99.0%。结论本测定方法简便,准确,可有效测定克霉唑阴道片中克霉唑的含量。

Objective To establish a method for determination of clotrimazole clotrimazole vaginal tablets content. Methods Using high performance liquid chromatography with ODS-C18 column,HYPERSIL（phi 4.6 mm×250.0 mm）, particle size of 5 mu m as analytical column,the solution of potassium hydrogen phosphate two（take two 4.35 G potassium hydrogen phosphate,dissolved in water and diluted to 1 000 ml）-methanol（1：3）as mobile phase,the flow rate is 1 ml/min, the detection wavelength was 254 nm.Results Clotrimazole in 0.1-5.0 μg/ml range has a good linear relationship. r=0.9999,the average recovery was 99.0%.Conclusion This method was simple,accurate the content can effectively determine the Clotrimazole Vaginal Tablets in clotrimazole.