高效液相色谱法测定注射用盐酸石蒜碱硫酯含量  

Content Determination of Lycorine Thiolate Hydrochloride for Injection by High Performance Liquid Chromatography

作　　者：李国相 车颜婷 张成宇 林彬 张威风 何淑旺 Li Guoxiang;Che Yanting;Zhang Chengyu;Lin Bin;Zhang Weifeng;He Shuwang(Beijing Dyne High-Tech Pediatric Pharmaceutical R&D Institute Co.,Ltd.,Beijing 100176,China;Shandong University,Jinan 250100,China;Shandong Dyne Marine Organism Pharmaceutical Co.,Ltd.,Shandong Weihai 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：《儿科药学杂志》2024年第10期10-13,共4页Journal of Pediatric Pharmacy

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

摘　　要：目的:基于高效液相色谱(HPLC)法开发一种注射用盐酸石蒜碱硫酯的含量测定方法。方法:色谱柱Kromasil(C18,4.6 mm×250 mm,5μm);流动相为甲醇-0.01 mol/L磷酸二氢钾(氢氧化钾调节pH至8.0)(80∶20);流速1.0 mL/min;检测波长290 nm;进样量10μL;柱温25℃。结果:经实验研究结果证明在该方法下,盐酸石蒜碱硫酯在0.08~0.32 mg/mL浓度范围内呈良好的线性关系(r=0.9998),平均回收率为99.7%,相对标准偏差(RSD)为0.9%(n=9)。用该方法对10个批次的自制品进行含量测定,结果均在98.0%~102.0%范围内。结论:本研究建立的方法具有简便、准确且重现性好等优点,可实现快速测定注射用盐酸石蒜碱硫脂的含量,以满足制剂大批量样品质量控制需求。Objective:To develop a method for content determination of lycorine thiolate hydrochloride for injection based on high performance liquid chromatography(HPLC).Methods:HPLC was performed on Kromasil(C18,4.6 mm×250 mm,5μm)by using a mobile phase of methanol-0.01 mol/L potassium dihydrogen phosphate(adjust with potassium hydroxide to a pH of 8.0)(80∶20)at a flow rate of 1.0 mL/min,and the analytes was detected at 290 nm.The injection volume was 10μL and the column temperature was maintained at 25℃.Results:Results of the experimental study demonstrated that lycorine thioester hydrochloride for injection showed good linearity(r=0.9998)in the concentration range of 0.08 to 0.32 mg/mL.The average recovery was 99.7%with relative standard deviation(RSD)of 0.9%(n=9).The content of 10 batches of self-manufactured products was determined by the method,the results were all in the range from 98.0%to 102.0%.Conclusion:The method has the advantages of simplicity,rapidity,high accuracy and good reproducibility,which can realize the rapid determination of lycorine thiolate hydrochloride for injection to meet the quality control requirements in large batches.

关 键 词：盐酸石蒜碱硫酯 高效液相色谱 含量 

分 类 号：R917[医药卫生—药物分析学]