盐酸法舒地尔注射液有关物质检查方法的研究  

Analysis of related substances in fasudil hydrochloride injection

作　　者：周健鹏 田勇 王卫 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2018年第1期24-27,共4页Tianjin Pharmacy

摘　　要：目的:建立了HPLC法测定盐酸法舒地尔注射液的有关物质。方法:色谱柱为Phenomenex Prodigy ODS C18柱(250 mm×4.6 mm,5μm),以缓冲液(取0.25 g四丁基硫酸氢铵,0.5%三乙胺溶液溶解并稀释至1 000 ml,磷酸调p H至6.5)-甲醇(90∶10)为流动相A,甲醇为流动相B,梯度洗脱,检测波长275 nm,流速:1.0 ml/min,柱温:30℃。结果:在选定的条件下,法舒地尔与杂质A、B、C、D分离良好;4个杂质的平均回收率分别为101.2%、98.6%、96.3%和100.7%,RSD分别为1.0%、0.5%、0.1%和0.3%;且上述4种杂质在0.15~0.75μg/ml浓度范围内线性关系良好。结论:经方法学验证,本法简便、专属、准确,可用于盐酸法舒地尔注射液中有关物质的测定。Objective: To establish an HPLC method for the determination of related substances in fasudil hydrochloride injection. Method: A Phenomenex Prodigy ODS( 250 mm × 4. 6 mm,5 μm) column was used with column temperature of 30 C; gradient elution was employed and the flow rate was 1. 0 ml/min. The related substances were measured at a wavelength of 275 nm with a UV detector. Results: Fasudil and its four impurities( A、B、C、D) were well separated. The average recovery of the four impurities were 101. 2%,98. 6%,96. 3% and 100. 7%,respectivey. Linearity was observed within the range of 0. 15 ~ 0. 75 μg/min for all the analytes. Conclusion: This method was simple,specific,accurate and suitable for analyzing the related substances in fasudil hydrochloride injection.

关 键 词：高效液相色谱法 盐酸法舒地尔注射液 有关物质 

分 类 号：R927.1[医药卫生—药学]