| 本文已被：浏览 1125次 下载 1622次 |
码上扫一扫！ |
| 高效液相色谱法测定注射用盐酸石蒜碱硫酯含量 |
| 李国相1,车颜婷1,张成宇1,林彬1,张威风1,2,3,何淑旺1,3 |
|
|
| ((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)) |
|
| 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,5 μm);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10 μL;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. 999 8),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。 |
| 关键词: 盐酸石蒜碱硫酯 高效液相色谱 含量 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.10.003 |
|
| 基金项目: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。 |
|
| Content Determination of Lycorine Thiolate Hydrochloride for Injection by High Performance Liquid |
| Li Guoxiang1, Che Yanting1, Zhang Chengyu1, Lin Bin1, Zhang Weifeng1,2,3, He Shuwang1,3 ( |
| ((1. Beijing Dyne High-Tech Pediatric Pharmaceutical R&D Institute Co. , Ltd. , Beijing 100176, China; 2. Shandong University, Jinan 250100, China; 3.Shandong Dyne Marine Organism Pharmaceutical Co. , Ltd. , Shandong Weihai 264300, China)) |
| Abstract: |
| 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, 5 μm) 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 10 μL 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. 999 8) 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. |
| Key words: lycorine thioester hydrochloride high performance liquid chromatography content |
