Determination of Indapamide and Its Enantiomer by Supercritical Fluid Chromatography
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.
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