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
李国相 1张威风 2车颜婷 1张成宇 1林彬 1何淑旺3
作者信息
- 1. 北京达因高科儿童药物研究院有限公司,北京 100176
- 2. 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
- 3. 北京达因高科儿童药物研究院有限公司,北京 100176;山东达因海洋生物制药股份有限公司,山东威海 264300
- 折叠
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,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.
Abstract
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.
关键词
盐酸石蒜碱硫酯/有关物质/高效液相色谱法Key words
Lycorine thiolate hydrochloride/Related substances/HPLC引用本文复制引用
基金项目
中国博士后科学基金(2020M672078)
山东省自然科学基金青年项目(ZR2021QH360)
出版年
2024
NETL
NSTL
万方数据