清洁效果验证中硫酸卷曲霉素残留量分析方法建立  

Establishment of Analytical Method of Capreomycin Sulfate Residual in Cleaning Effect validation

作　　者：韦翠 彭志兴 

机构地区：[1]南宁中科药业有限责任公司,广西南宁530003 [2]广西化工实验厂,广西南宁530031

出　　处：《化工技术与开发》2013年第5期36-38,共3页Technology & Development of Chemical Industry

摘　　要：注射用硫酸卷曲霉素无菌分装过程需要对分装机清洁效果进行验证,本文利用高效液相色谱法对清洁验证最终淋洗水中硫酸卷曲霉素残留量进行检测。色谱条件:以C18色谱柱为固定相,以0.016mol.L-1己烷磺酸钠溶液-甲醇-乙腈-冰醋酸(70∶25∶25∶2,v/v)为流动相,流速为1mL.min-1,紫外检测波长254nm,柱温为常温。结果表明,该方法系统适用性、线性、精密度均符合清洁验证活性物质检测方法要求,可用于清洁效果验证中硫酸卷曲霉素残留量的检测。The cleaning effect of packaging machine needed essential validation in the sterile separation packed process of capreo- mycin sulfate for injection. The residue of the active substance in final rinse water of cleaning validation were determined by HPLC on the column C18 with elution （flow rate： 1.0mL/min）, 0.016mol/L hexane sodium solution-methanol-acetonitrile-acetic acid （70 ： 25 ： 25 ： 2,v/v） mixture as mobile phase, UV detection at 254nm. The results showed that suitability, linearity and precision of cleaning validation systemmeet met the analysis demand of the active substance. The method could be applied to the detection of ca- preomycin cleaning effect validation of neomycin residues.

关 键 词：清洁验证 硫酸卷曲霉素残留量 高效液相色谱法 

分 类 号：O652.63[理学—分析化学]