HPLC法测定盐酸丁咯地尔胶囊有关物质

Determination of Related Substance in Buflomedil Hydrochloride Capsules by HPLC

目的:为了更好地对盐酸丁咯地尔胶囊进行质量控制,提高质量标准,增加有关物质测定方法和限度。方法:参照新药转正标准WS1-(X-246)-2004Z盐酸丁咯地尔胶囊中"含量测定"项下检查方法,采用Inertsil ODS-SP,4.6mm×150mm×5μm色谱柱,以甲醇-水-冰醋酸-三乙胺(200:350:0.8:1.0)为流动相,流速为1.0m·lmin-1,检测波长为282nm,进样量20μl。结果:该药品溶液稳定,定量限为2ng,检测限为0.8ng,盐酸丁咯地尔峰理论塔板数:n=1607.106,符合中国药典2010年版二部附录V D之规定。结论:本方法简便准确,重现性好,能有效测定盐酸丁咯地尔胶囊有关物质的含量。

Objective： In order to better control the quality of Buflomedil Hydrochloride Capsules, increasing the determination method of related substances and limits to improve the quality standard. Methods：According to the inspection method of Buflomedil Hy- drochloride Capsules of new drug official standard WS1 - （ X-246 ） - 2004Z, method is used that Inertsil ODS-SP, 4.6ram x 150ram x 5 μ m column chromatography, methanol - water - acetic acid - TEA （ 200 ： 350： 0.8： 1） as mobile phase, flow rate as 1.0ml rain-l, de- tection wavelength as 282nm, amount of sample 20 p. L. Results：The drug solution is stable, the limit of quantitation is 2ng and the limit of detection is 0.8ng, the number of theoretical plates is 1607.106, which is in line with the Chinese Pharmacopoeia. Conclusion：This method is simple, accurate, reproducible, and can effectively test the amount of related substances of Buflomedil Hydrochloride Capsules.