反相高效液相色谱法测定克林霉素磷酸酯栓的有关物质和降解产物

Determination of Related Substances and Degradation Substances of Clindamycin Phosphate Suppository by RP-HPLC

[目的 ]用反相高效液相色谱法测定克林霉素磷酸酯栓的有关物质和降解产物。 [方法 ]色谱柱为辛烷基硅烷键合硅胶填充柱 ,流动相为 :乙腈 -磷酸二氢钾缓冲液 (13.6克溶于 10 0 0 m l水中 ,用磷酸调节 p H 2 .5 ,2 10∶790 ) ,检测波长 :2 10 nm。 [结果 ]本法经紫外二级管阵列检测器对所做图谱中有关物质和降解产物色谱峰进行纯度分析 ,各色谱峰均有良好纯度 ,原料中带入的有关物质和强力破坏条件下的降解产物与主组分有较好的分离度。[结论

To establish a RP-HPLC method for the determination of the related substances and degradation substances of Clindamycin Phosphate suppository Chromatographic conditions were as follows: column: C 8; mobile phase: Acetonitrile-KH 2PO 4 Buffer (210∶790); the detective wavelength: 210nm. The resolutions between Clindamycin and other impurity substances were very good and the purities of all peaks were about or above 99.9%. [CONCLUSION] This method is suitable for controlling the quality of Clindamycin Phosphate Suppository.