抗结核固定剂量复方制剂有关物质的测定  

Determination of the Related Substances of Antituberculosis Fixed-dose Combination

作　　者：李冰[1] 姚兰[1] 孙晓军[1] 

机构地区：[1]辽宁省食品药品检验所,辽宁沈阳110023

出　　处：《中国医药工业杂志》2012年第3期208-211,共4页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定抗结核固定剂量复方制剂(FDC)品种异福片、异福酰胺片及乙胺吡嗪利福异烟片中的有关物质。采用C18色谱柱,以0.01 mol/L磷酸盐缓冲液-甲醇(40︰60)为流动相,检测波长254 nm。经专属性试验、系统适用性试验、耐用性试验和溶液稳定性试验证实方法可行,增加有关物质的测定方法有利于其复方制剂药品质量的控制。An HPLC method was established for the determination of the related substances of antituberculosis fixed-dose combination （FDC） of rifampin, isoniazid and pyrazinamide. A C18 column was used with the mobile phase of 0.01 mol/L phosphate buffer-methanol （40 ： 60） at the detection wavelength of 254 nm. The results of specificity test, system suitability test, durability test and solution stability test showed that the proposed method was feasible. The determination of related substances is beneficial to the quality control of compound drugs.

关 键 词：抗结核 固定剂量复方制剂 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]