梯度洗脱HPLC法测定盐酸克林霉素棕榈酸酯及制剂的有关物质  

Isocratic HPLC determination of related substances of clindamycin palmitate hydrochloride and its drug products

作　　者：王建[1] 王红波[2] 孟磊[3] 洪利娅[1] 

机构地区：[1]浙江省食品药品检验所,杭州310004 [2]浙江工业大学,杭州310004 [3]蚌埠医学院,蚌埠233000

出　　处：《药物分析杂志》2012年第2期314-317,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药典委员会国家药品标准提高研究项目;编号国药典综发[2010]35号

摘　　要：目的:建立梯度洗脱HPLC法测定盐酸克林霉素棕榈酸酯原料药、分散片、颗粒及干混悬剂的有关物质。方法:采用Agilent ZORBAX XDB-C8(4.6 mm×150 mm,5μm)柱,流动相A为5 mmol·L-1醋酸铵溶液-乙腈(50∶50),流动相B为乙腈,流速为1.0 mL·min-1,线性梯度洗脱,检测波长为230 nm。结果:盐酸克林霉素棕榈酸酯与10种中间体、副产物完全分离。重复性RSD为2.9%,检测限为10μg·mL-1。结论:方法简便、灵敏、重复性好,可用于本品的质量控制。Objective ： To develop isocratic HPLC method for the determination of related substances of clindamycin palmitate hydrochloride drug substance,dispersible tablets, granules and for suspension. Methods：The column was Agilent ZORBAX XDB - Cs （4. 6 mm×150 mm,5 μm. The mobile phase consisted of 5 mmol· L-lammonium acetate solution- acetonitrile（50：50 ）（A） and acetonitrile （B） with gradient program. The flow rate was 1.0 mL min-1, and the detection wavelength was 230 nm. Results：Good separation of clindamycin palmitate and ten inter- mediates could be achieved. The RSD of precision was 2.9%. The detection limit was 10 g mL-1. Conclusion： The method is simple, sensitive and reproducible, and can be used for quality control of clindamycin palmitate hydrochloride.

关 键 词：盐酸克林霉素棕榈酸酯 杂质 中间体 副产物 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]