山西大学学报（自然科学版）2024，Vol.47Issue(1)：207-213,7.DOI:10.13451/j.sxu.ns.2023052
高效液相色谱法测定甲硝唑原料药中有关物质及稳定性研究
Determination of Related Substances of Metronidazole Raw Material by HPLC and Study on Its Stability
摘要
Abstract
The related substances in metronidazole was detemined by High-performance liquid chromatography and the stability of raw materials was studied with different factors.HPLC was performed on the column of Athena C18-WP with mobile phase of metha-nol-water(25∶75,V/V)at a flow rate of 1.0 mL/min,the detection wavelength was 315 nm,the column temperature was 25℃,and the injection volume was 20 µL.The stability of metronidazole raw materials under high temperature,high humidity,intense light was investigated.Under the optimized conditions,metronidazole and related substances could be separated well,the linear range of impurity I(2-methyl-5-nitroimidazole)concentration was 4.8-479.2 ng/mL(r = 0.999 9),limit of quantitation was 15.3 ng/mL,lim-it of detection was 4.8 ng/mL,relative sandard deviation(RSD)of precision,stability and repeatability tests were lower than 10.0%,and recovery was 103.77%-108.61%(RSD%= 1.48%).The raw material of Metronidazole is relatively stable under the conditions of high temperature,high humidity and intense light.The method is simple,accurate and can be used for the determina-tion of related substances in metronidazole raw material.The stability of metronidazole is very good,which provides a basis for the study of metronidazole quality control and its related preparations.关键词
甲硝唑/高效液相色谱法/定量测定/稳定性/质量控制Key words
metronidazole/high performance liquid chromatography/quantitative detection/stability/quality control分类
医药卫生引用本文复制引用
张文琴,叶松华,阮文辉,王晓燕,王进东..高效液相色谱法测定甲硝唑原料药中有关物质及稳定性研究[J].山西大学学报（自然科学版）,2024,47(1):207-213,7.基金项目
山西省省属科研院所技术开发实验室建设项目 （）
