HPLC法测定注射用盐酸石蒜碱硫酯的有关物质  

Determination of Related Substances of Lycorine Thiolate Hydrochloride for Injections by HPLC

作　　者：李国相 张威风 车颜婷 张成宇 林彬 何淑旺 LI Guoxiang;ZHANG Weifeng;CHE Yanting;ZHANG Chengyu;LIN Bin;HE Shuwang(Beijing DYNE High-tech Pediatric Pharmaceutical R&D Institute Co.Ltd.,Beijing 100176,China;Shandong University,Ji’nan 250100,China;Department of Pharmaceutical Development,Shandong Dyne Marine Biopharmaceutical Limietd Corporation,Weihai,Shandong 264300,China)

机构地区：[1]北京达因高科儿童药物研究院有限公司,北京100176 [2]山东大学,济南250100 [3]山东达因海洋生物制药股份有限公司,山东威海264300

出　　处：《药学与临床研究》2024年第4期289-292,共4页Pharmaceutical and Clinical Research

基　　金：中国博士后科学基金(2020M672078);山东省自然科学基金青年项目(ZR2021QH360)。

摘　　要：目的:采用高效液相色谱法测定注射用盐酸石蒜碱硫酯的有关物质。方法:色谱柱:Kromasil(C18,4.6 mm×250 mm,5μm);流动相:以磷酸盐缓冲液为流动相A,以乙腈为流动相B,梯度洗脱;流速1.2 mL·min^(-1);柱温40℃;检测波长290 nm;进样量10μL。结果:盐酸石蒜碱硫酯和各杂质之间均实现有效分离,在LOQ浓度至200%限度浓度范围内具有良好的线性关系,且各杂质在低、中、高3个浓度的平均回收率为96.8%~103.6%。结论:此法具有准确度高、重现性好且简单快速等优点,可用于注射用盐酸石蒜碱硫酯的质量控制。Objective:A liquid chromatography(HPLC)method was developed to determine related substances in lycorine thiolate hydrochloride for injections.Methods:A chromatographic column of Kromasil C18(4.6 mm×250 mm,5μm)was used for the HPLC method.Phosphate buffer was used as mobile phase A and acetonitrile as mobile phase B for gradient elution.The flow rate was 1.2 mL·min^(-1)with column temperature contained at 40°C.The detection wavelength was 290 nm.The injection volume was 10μL.Results:Lycorine thiolate hydrochloride and its impurities were effectively separated in this method.Good linearity were obtained in the ranges of LOQ concentrations to 200%limit concentrations.The average recoveries among the low,middle and high concentrations were from 96.8%to 103.6%.Conclusion:This method has the advantages of high accuracy,good reproducibility,simplicity and rapidity,which can be used for the quality control of lycorine thiolate hydrochloride for injections.

关 键 词：盐酸石蒜碱硫酯 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]