煤炭与化工2024，Vol.47Issue(11)：136-139,4.DOI:10.19286/j.cnki.cci.2024.11.031
恩格列净原料药含量的方法学验证
Methodological validation of empagliflozin API content
郑小霞 1姜鹏鹏 1王丽霞 1梁丙辰 1刘艳君 1张凤娜 1岳思琪1
作者信息
- 1. 河北合佳医药科技集团股份有限公司,河北 石家庄 052165||河北合佳医药科技集团中央研究院,河北石家庄 050035
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摘要
Abstract
In order to establish the HPLC determination method of empagliflozin API content,the content of empagliflonet drug substance was quantified by ACE Excel C18(4.6 × 150 mm,5 μm)column,with 0.1％acetic acid solution as phase A,methanol as mobile phase B,mobile phase A-phase B(75∶25),flow rate 1.0 mL/min,temperature of 30 ℃,and detection wavelength was 220 nm.Results show that the applicability of the system met the requirements,the blank solvent did not interfere with the determination of empagliflozdrug substance;the mass concentration within 0.030 03～0.450 4 mg/mL showed good linear relationship with the peak area(r=0.999 9).In the repetitive experiment,the RSD value of the content in the test article is less than 2％;the peak area is 98.0％～102.0％in the initial 0 hours;in the durability test,the RSD value of the content under different parameters is less than 2.0％.This method has high specificity,high sensitivity,repeatability and durability,and can be used as a method of API content and provide reliable guarantee for the quality and efficacy of subsequent synthesized empagliflozin.关键词
恩格列净/高效液相色谱法/方法学验证/原料药/含量Key words
empagliflozin/high performance liquid chromatography(HPLC)/methodology validation/API/content分类
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郑小霞,姜鹏鹏,王丽霞,梁丙辰,刘艳君,张凤娜,岳思琪..恩格列净原料药含量的方法学验证[J].煤炭与化工,2024,47(11):136-139,4.
