中国标准化Issue(5)：216-220,5.DOI:10.3969/j.issn.1002-5944.2024.05.036
达格列净中特定杂质分析及稳定性研究
Analysis and Stability Study of Specific Impurities in Dapagliflozin
摘要
Abstract
To establish an analysis method for specific impurity DGL301 in dapagliflozin,the tetradecanoic acid propionamide group bonded silica gel was used as the filler(Poroshell 120 Bonus-RP,100mm×4.6mm,2.7 μm or equivalent chromatographic column);mobile phase A:0.085％phosphoric acid aqueous solution,mobile phase B:acetonitrile;the volume flow rate was controlled to 1.0 mL/min for gradient elution;the detection wavelength was 225 nm;the column temperature was 25℃;the injection volume was 10 μL.Under optimized chromatographic conditions,the separation of the main peak,specific impurity DGL301,and other impurities met the requirement;specific impurity DGL301 was in the concentration range of 0.16 to 0.79 μg/mL,showing a good linear relationship.The regression equation was A=24.869C+0.5787,r=0.9992;the detection limit was 17.56 ng·mL-1;the quantification limit was 59.85 ng·mL-1,RSD=0.9％(n=6);and the average recovery rate was 98.37％(n=9).This method can be used for the detection of specific impurity DGL301 in dapagliflozin.关键词
达格列净/特定杂质/高效液相色谱法Key words
dapagliflozin/specific impurity/high performance liquid chromatography引用本文复制引用
范祥元,杜陈侠..达格列净中特定杂质分析及稳定性研究[J].中国标准化,2024,(5):216-220,5.基金项目
本文受安徽省自然基金项目"基于植物分类学与分子网络技术的贝母属药材止咳、化痰'属效标志物'研究"(项目编号:2108085MB63)资助. （项目编号:2108085MB63）
