HPLC法测定克林霉素磷酸酯注射液中抑菌剂苯甲醇的含量

Content Determination of Bacteriostatic Agent Benzyl Alcohol in Clindamycin Phosphate Injection by HPLC

目的:建立高效液相色谱法测定克林霉素磷酸酯注射液中抑菌剂苯甲醇含量的方法。方法:采用色谱柱为CAPCELL PAKC8,流动相为磷酸二氢钾溶液-乙腈(775:225),流速为1.0mL·min^(-1),检测波长为210nm。结果:苯甲醇检测浓度线性范围为4.175～41.75μg·mL^(-1)(r=0.9999),平均加样回收率为100.5%(n=9),RSD=0.09%。结论:本方法准确、重复性好,可用于克林霉素磷酸酯注射液中苯甲醇含量的测定。

OBJECTIVE：To establish HPLC method for the content determination of bacteriostatic agent benzyl alcohol in Clindamycin phosphate injection.METHODS：The determination was performed on CAPCELL PAK C8 column using potassium dihydrogen phosphate solution-acetonitrile（775：225）as mobile phase at flow rate of 1.0 mL·min^-1.The detection wavelength was set at 210 nm.RESULT：The linear range of benzyl alcohol was 4.175～41.75 μg·mL^-1（r=0.999 9）with an average recovery of 100.5%（n=9）,RSD=0.09%.CONCLUSION：The method is accurate and reproducible for the content determination of benzyl alcohol in Clindamycin phosphate injection.