克林霉素磷酸酯葡萄糖注射液中有关物质的研究  

Study on the related substances in clindamycin phosphate glucose injection

作　　者：张斗胜[1] 李进[1] 姚蕾[1] 相秉仁[2] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国药科大学分析测试中心,南京210009

出　　处：《药物分析杂志》2008年第8期1288-1292,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:改进克林霉素磷酸酯葡萄糖注射液有关物质测定方法,并对杂质归属进行分析。方法:通过对流动相的优化改进测定条件;运用色谱相关光谱法等技术结合加速实验对各有关物质进行归属。结果:改进的方法使主成分与紧邻杂质达到基线分离,其他杂质也分离较好;比对保留时间和紫外光谱,确证样品中有关物质主要有:林可霉素(RRT=0.31)、5-羟甲基糠醛(RRT=0.37)、克林霉素(RRT=1.47)和酸降解杂质(RRT=0.33,0.71,0.77,0.82)及未知合成杂质(RRT=0.49)。结论:改进后的方法测定更准确,耐用性良好,适用于不同剂型的测定;克林霉素磷酸酯溶液在高温条件下主要产生林可霉素与克林霉素,目前其制剂中的其他杂质主要是其酸降解产物。Objective：To modify method for determination of related substances in clindamycin phosphate glucose injection and analyze the attribution of them. Methods：The test condition was modified by optimization of the mobile phase, and the related substances were attributed by the chromatograph - spectra correlation method and related degradation tests. Results：The principale component and its related impurity were well separated from each other, and by comparison with the retention time and ultraviolet spectra of the standards, the major related substances were identified, including lincomycin（ RRT = 0. 31 ）, 5 - hydroxymethyl Furaldehyde （ RRT = 0. 37 ）, Clindamycin （ RRT = 1.47）,the impurities produced by acid degradation（ RRT =0.33,0. 71,0. 77,0. 82 ）and one unknown synthesis impurity （ RRT = 0. 49 ）. Conclusion ： The modified method could be applied for analyzing different preparations, and better accuracy and robustness were obtained in the application. The clindamycin phosphate solution was mainly degraded into lincomycin and clindamycin under high temperature condition, and most of other impurities in the injection were identified as acid degradation products.

关 键 词：克林霉素磷酸酯葡萄糖注射液 有关物质 方法改进 归属 

分 类 号：R917[医药卫生—药物分析学]