煤炭与化工2025，Vol.48Issue(5)：156-160,5.DOI:10.19286/j.cnki.cci.2025.05.033
高效液相色谱法测定米拉贝隆原料药含量
Determination of mirabegron API content by high performance liquid chromatography
董永广1
作者信息
- 1. 河北冀衡药业股份有限公司,河北衡水 053400
- 折叠
摘要
Abstract
In order to develop a method for the determination of mirabelone API content,high performance liquid chromatography(HPLC)was used.The chromatographic column was GLInertsil ODS-3 C-18 column(4.6 mm × 250 mm,5 μ m).Mobile phase:using a buffer solution(0.1％phosphoric acid solution,pH vaule adjusted to 6.0 with triethylamine)∶methanol=65∶35(V/V);flow rate:1.0 mL/min;detection wavelength:210 nm;injection volume:10 μL;column temperature:30 ℃.The results show that the test sample concentration of milaberone 0.25 to 0.75 mg/mL presents good linear relationship,the linear equation was y=725.53x-2.178(r2=0.999 7);the detection limit was 0.167 μg/mL,the quantitative limit was 0.624 μ g/mL;the RSD of the 48 h solution stability test is 0.27％;the RSD of the repeatability test is 0.15％(n=6);the RSD of the intermediate precision test is 0.12％(n=12);the average recovery rate is 99.61％(RSD of 0.79％);the content of three batches of raw drug samples determined by this method is within the range of 98.0％to 102.0％.The results show that the data obtained by this method are stable,reliable,reproducible and stable,and the chromatographic conditions are durable,which can be used to determine the content of Mirabelone.关键词
高效液相色谱法/米拉贝隆/原料药/含量测定Key words
high performance liquid chromatography/mirabegron/API/content determination分类
化学化工引用本文复制引用
董永广..高效液相色谱法测定米拉贝隆原料药含量[J].煤炭与化工,2025,48(5):156-160,5.
