中国药业2024，Vol.33Issue(12)：75-78,4.DOI:10.3969/j.issn.1006-4931.2024.12.017
超临界流体色谱法测定吲达帕胺及其对映异构体含量
Determination of Indapamide and Its Enantiomer by Supercritical Fluid Chromatography
林丽琴 1汪霞 1杨直 1高丽琼 1彭彦 1石云峰2
作者信息
- 1. 浙江省杭州市食品药品检验科学研究院,浙江 杭州 310022
- 2. 浙江省食品药品检验研究院,浙江 杭州 310052
- 折叠
摘要
Abstract
Objective To establish a supercritical fluid chromatography(SFC)method for effectively separating the enantiomer of indapamide and determining its content.Methods The chromatographic column was the Daicel IB N-5 column(250 mm×4.6 mm,5 μm),the mobile phase was carbon dioxide-0.1%diethanolamine methanol solution(70∶30,V/V),the back pressure was 150 bar,the flow rate was 3.0 mL/min,the detection wavelength was 243 nm,the column temperature was 40℃,and the injection volume was 5 μL.Results Indapamide and its enantiomer were separated successfully in 5 min with a good resolution.The linear ranges of the two components were 2.48-37.10 μg/mL(r=0.999 9,n=6).The limits of detection for both were 0.012 μg/mL,and the limits of quantification for both were 0.05 μg/mL.The RSDs of precision and stability tests were lower than 1.0%.The durability was good.The average recovery rates of indapamide and its enantiomer were 100.75%and 100.90%,with RSDsof 1.00%and 0.72%respectively(n=9).Conclusion The established SFC method is accurate and durable,which can effectively determine the contents of indapamide and its enantiomer in Indapamide Tablets.关键词
吲达帕胺/超临界流体色谱法/手性拆分/对映异构体/含量测定Key words
indapamide/supercritical fluid chromatography/chiral separation/enantiomer/content determination分类
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林丽琴,汪霞,杨直,高丽琼,彭彦,石云峰..超临界流体色谱法测定吲达帕胺及其对映异构体含量[J].中国药业,2024,33(12):75-78,4.
