注射用克林霉素磷酸酯质量标准研究

Study on Quality Standard of Clindamycin Phosphate for Injection

为注射用克林霉素磷酸酯提供了质量控制方法。采用高效液相法进行含量测定和有关物质检查 ,用 Hypersil C1 8柱 ,流动相为磷酸二氢钾溶液 -乙腈 (775 :2 2 5 ) ,检测波长 2 10 nm ,克林霉素磷酸酯在 1.32～ 10 .3μg范围内有良好的线性关系 (r=0 .9999,n=5 ) ,平均回收率为 99.5 9% (RSD% =1.3% ) ,最低检测限为 2 .9ng。建立的含量测定外标法及有关物质检查法简便、准确、专属性好。建议修订标准时采用 ,以有效控制产品的质量 。

The mobil phase consists of sodium dihydrogen phosphate solution acetonitrile (775∶225). Detection was performed with UV detecter at 210 nm. The calibration curve for clindamycin phosphate was linear (1.32～\{10.36\} μg, r=0.9999,n=5) . The average recovery of the assay was 99.65%( RSD %=1.3%). The limit of detection for Clindamycin Phosphate was 2.9 ng. The method had the advantage of simplicity, accuracy and reliability, and it may be used for the quantitative determination of Clindamycin Phosphate for Injection.