文档介绍：HPLC-ELSD法分析注射用硫普罗宁含量及有关物质
陈来景,郭庭莉,刘鸿敏,张冬云
(河南省新谊药业股份有限公司,河南新乡453731)
[摘要] 目的:建立注射用硫普罗宁含量及有关物质高效液相色谱—蒸发光散射检测器(HPLC-ELSD)检测方法。方法:采用Kromasil C18(250mm ×,5μm)色谱柱;柱温30℃;甲醇—%醋酸溶液(20:80)为流动相; ml·min-1;蒸发光散射检测器漂移管温度44℃,,撞击器开。结果:~(r=),%,。结论:方法快速、简便,结果准确可靠,重复性好。
[关键词] 注射用硫普罗宁;含量;有关物质;高效液相色谱法;蒸发光散射检测器
中图分类号:R917 文献标识码:A
HPLC-ELSD Analysis of Tiopronin for Injection and Its Related Substances
Chen Lai-jing,GUO Ting-li,Liu Hong-min,Zhang Dong-yun
(Henan Xin-Yi Pharmaceutical Co., Ltd.,Xinxiang Henan 453731)
[Abstract] Objective: To develop an HPLC-ELSD method for the determination of Tiopronin for Injection and its related substances method . Methods: The column:Kromasil C18 (250mm × , 5 μ m).The column temperature: 30 ℃.The mobile phase: methanol -% acetic acid (20:80).Flow rate: ml·min-1. The Drift tube temperature: 44 ℃. Gas Operation Pressure: on . Results:The calibration curve was linear in the rang of ~(r=). The repeatability(RSD) was %. The limit of detection and quantification were μ g and g respectively. Conclusion: The method is simple and rapid,the results are accurate and reproducible.
[Key words] Tiopronin for Injection; Content Determination; related substances; HPLC; ELSD
硫普罗宁(Tiopronin),化学名N-(2-巯基丙酰基)-甘氨酸,首