HPLC法测定注射用苦参素中的有关物质及方法学研究  

Determination and Methodology Research of Related Substances in Marine for Injection by HPLC

作　　者：翟宇 尚博扬 黄青[2] ZHAI Yu;SHANG Boyang;HUANG Qing(Ningxia Institute for Drug Control,Ningxia Key Laboratory of Drug Creation and Generic Pharmaceutical Research,Yinchuan 750004,China;Ningxia Medical University,Yinchuan 750004,China)

机构地区：[1]宁夏回族自治区药品检验研究院宁夏药物创制与仿制药研究重点实验室,银川750004 [2]宁夏医科大学,银川750004

出　　处：《宁夏医科大学学报》2019年第2期211-214,共4页Journal of Ningxia Medical University

基　　金：宁夏药物创制与仿制药研究重点实验室开放课题

摘　　要：目的建立高效液相色谱法测定注射用苦参素中有关物质的方法,并进行方法学研究。方法采用PLATISIL C18柱(4.6mm×250mm,5μm),流动相为0.05mol·L^(-1)磷酸二氢钾溶液(磷酸调节pH值为3.5):甲醇(82∶18),流速1.0mL·min^(-1),检测波长215nm,柱温30℃。结果氧化槐果碱在2.09～12.54μg·L^(-1)浓度范围内线性良好(r=0.9999),平均回收率为101.1%(RSD=0.7%)。结论本HPLC法测定注射用苦参素中的有关物质操作简便,结果准确可靠。Objective To establish an HPLC method for determination and methodology research of related substances in marine for injection.Methods It was performed on the PLATISIL C18 column(4.6mm×250mm,5μm)and a mobile phase of potassium dihydrogen phosphate solution(0.05mol·L^-1,pH3.5)-methanol(82∶18)with a flow rate of 1.0mL·min^-1.The detection wavelength was at 215nm and the column temperature was 30℃.Results The calibration curve of oxysophocarpine was in the range of 2.09~12.54μg·mL-1(r=0.9999),and the average recovery was 101.1%(RSD=0.7%).Conclusion The determination of related substances in matrine for injection by HPLC method is simple,accurate and reliable.

关 键 词：注射用苦参素 高效液相色谱法 有关物质 氧化槐果碱 

分 类 号：R284.1[医药卫生—中药学]