摘要
目的建立甲钴胺片清洁验证分析方法及取样方法.方法采用髙效液相法,以H ypersilODS2 -C18 （5 μm,4.6×150 mm ）为色谱柱,以0.05 mol/L 乙酸铵溶液- 乙腈（8317）为流动相,流速为1.0mL /min,检测波长为266nm ,进样量为20L ,柱温30 ℃.结果甲钴胺对照品溶液在检测浓度0.03 - 1.60μg /m L 范围内线性关系良好（r= 0.999）,且回收率符合要求（回收率为99% ） .结论该方法简便、准确、重复性好,灵敏度髙,可用于甲钴胺片清洁验证药品残留量的检测.
Objective To establish a validated analytical m ethod of m ecobalam in tablets cleaning and sam pling method.Methods The high perform ance liquid chrom atography was adopted with H ypersil O D S2-C 18 （5μm, 4.6×150 mm） column,with 0.05 mol/L ammonium acetate solution- acetonitrile （8317） as the mobile phase at a flow rate of 1.0 mL/min. The absorbancewas m onitored at 266 nm. The injection volume was 20μl and the colum n tem perature was 30℃. Results Theliner correlation of m ecobalam in contrast solution was good from the 0.03μg/mL to 1.60 μg/mL detection concentration R=0.999, and the recycle rate m et the requirem ent （the recycle rate was 99% ）. Conclusion The method is sim ple and accuratewith good repeatability and high sensitivity, which can be used in the detection of m ecobalam in tablets in the cleaning validationof drug residue.
出处
《中国卫生产业》
2016年第31期50-52,共3页
China Health Industry
关键词
甲钴胺片
清洁验证
方法学
M ecobalamin tablets
Cleaning validation
Methodology
