亲水作用色谱-串联质谱法同时测定瓜蒌皮注射液中35种化合物  

Simultaneously quantitative analysis of 35 components in gualoupi injection using hydrophilic interaction liquid chromatography tandem mass spectrometry

作　　者：陶香 张静娴 胡青 孙健 董莹 丁金国 于泓 沈盈盈 毛秀红 季申[1,2] TAO Xiang;ZHANG Jing-xian;HU Qing;SUN Jian;DONG Ying;DING Jin-guo;YU Hong;SHEN Ying-ying;MAO Xiu-hong;JI Shen(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;SPH No.1 Biochemical&Pharmaceutical Co.,Ltd.,Shanghai 200240,China)

机构地区：[1]上海中医药大学,上海201203 [2]上海市食品药品检验研究院,上海201203 [3]上海第一生化药业有限公司,上海200240

出　　处：《药学学报》2023年第5期1293-1300,共8页Acta Pharmaceutica Sinica

基　　金：上海市中药和保健食品品质与安全检测专业技术服务平台(21DZ2290200);上海市人才发展资金(2021085)。

摘　　要：采用亲水作用色谱-串联质谱的动态多重反应监测模式建立瓜蒌皮注射液中35种化合物的同时定量分析方法。采用ACQUITY XBridge Amide色谱柱分离,以20 mmol·L^(-1)甲酸铵水溶液(pH 3.0)为流动相A,20 mmol·L^(-1)甲酸铵溶液(pH 3.0)∶乙腈(1∶9)混合溶液为流动相B,进行梯度洗脱,采用外标法定量。结果表明,35种化合物在各自浓度范围内具有良好的线性关系,相关系数(R2)>0.9980,方法回收率范围为77.6%~118.5%。采用建立好的方法测定了10批样品,结果表明瓜蒌皮注射液中γ-氨基丁酸、葫芦巴碱、丙氨酸、苏氨酸、高丝氨酸、瓜氨酸、亮氨酸等成分含量较高,而烟酰胺、甲基琥珀酸、胞嘧啶、胆碱等成分含量较低。本研究为瓜蒌皮注射液的药效物质基础和质量标准提升研究提供了重要参考。A hydrophilic interaction chromatography tandem mass spectrometry method was developed for simultaneous quantification of 35 components in gualoupi injection.The analytes were separated with an ACQUITY XBridge Amide column using 20 mmol·L-1 ammonium formate aqueous solution(pH 3.0)as mobile phase A and 20 mmol·L-1 ammonium formate(pH 3.0)∶acetonitrile(1∶9)as mobile phase B for gradient elution.Mass spectrometry with dynamic multiple reaction monitoring and external standard method were used for quantitative analysis.A total of 35 components were determined in 10 batches of gualoupi injection.The results showed that the 35 compounds had a good linear relationship within their respective concentration ranges with the correlation coefficients(R2>0.9980),the recoveries ranged from 76.6%to 118.5%.The results showed thatγ-aminobutyric acid,trigonelline,alanine,threonine,homoserine,citrulline,and leucine were abundant in gualoupi injection,while nicotinamide,methylsuccinic acid,cytosine and choline account for a low percentege.The present study provides an important reference for elucidation of the effective material basis and the improvement of quality standard of gualoupi injection.

关 键 词：瓜蒌皮注射液 亲水作用色谱串联质谱 动态多重反应监测 多指标定量分析 

分 类 号：R917[医药卫生—药物分析学]