高效液相色谱法测定盐酸克林霉素凝胶的含量

Testing the Content of Klindamycin Hydrochloride Gel Using High Performance Liquid Chromatography

目的 :建立测定盐酸克林霉素凝胶含量的高效液相色谱法。方法 :流动相为磷酸二氢钾溶液 (pH 7.5 ) 乙腈 (5 5∶45 ) ,紫外检测波长 2 14nm。结果 :各组分分离度好 ,日内精密度RSD为 0 .7%～ 1.1% ,日间RSD 0 .9%～ 1.4% ,平均回收率 99.7% (n =5 ) ,RSD 1.2 % ,最低检测量 0 .2 5 μg·mL 1 。结论 :本方法简单易行 ,快速准确且分离度好 。

Objective:To establish the regime of testing the content of klindamycin hydrochloride gel by using high performance liquid chromatography (HPLC). Method:The mobile phase of the HPLC is composed of pH 7.5 potassium dihydrogen phosphate solution and acetonitrile (55∶45), the wavelength of the ultraviolet employed for test is 214 nm. Results:The sample resolution was very good, the within day and between day accurate RSDs were 0.7%～1.1% and 0.9%～1.4%, respectively. The average recovery was 99.7% ( n =5), RSD 1.2%, the lower detection limit was 0.25 μg·ml 1 . Conclusion:The method is simple, rapid, accurate and has good resolution. It is suitable for routine analysis of the klindamycin hydrochloride gel.