首页|HPLC法测定注射用盐酸石蒜碱硫酯的有关物质

HPLC法测定注射用盐酸石蒜碱硫酯的有关物质

扫码查看
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,5 μm);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10 μL。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。
Determination of Related Substances of Lycorine Thiolate Hydrochloride for Injections by HPLC
Objective:A liquid chromatography(HPLC)method was developed to determine related sub-stances in lycorine thiolate hydrochloride for injections.Methods:A chromatographic column of Kromasil C18(4.6 mm×250 mm,5 μm)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 tem-perature contained at 40℃.The detection wavelength was 290 nm.The injection volume was 10 μL.Re-sults: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 re-coveries 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.

Lycorine thiolate hydrochlorideRelated substancesHPLC

李国相、张威风、车颜婷、张成宇、林彬、何淑旺

展开 >

北京达因高科儿童药物研究院有限公司,北京 100176

山东大学,济南 250100

山东达因海洋生物制药股份有限公司,山东威海 264300

盐酸石蒜碱硫酯 有关物质 高效液相色谱法

中国博士后科学基金山东省自然科学基金青年项目

2020M672078ZR2021QH360

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
年,卷(期):2024.32(4)