Determination of dexlansoprazole and its isomers by HPLC
Objective To establish an HPLC method to determinate the content and isomers of dexlansoprazole.Methods For the content detection of dexlansoprazole,ZORBAX XDB-C18(4.6 mm × 250 mm,5 μm)was used with methanol-water-triethylamine-phosphate(400∶600∶5∶1.5)[adjusting pH to 7.3 with phosphoric acid solution(1 → 10)]:methanol(55:45)as the mobile phase,eluted at a flow rate of 1.0 mL·min-1.The column temperature maintained at 30 ℃ and the detection wavelength was set at 284 nm.For the detection of isomers,CHIRALCEL OZ-3R(4.6 mm × 150 mm,3 μm)was used with 0.05 mol·L-1 sodium dihydrogen phosphate solution-acetonitrile(60∶40)as the mobile phase.Results The calibration curve of dexlansoprazole and its isomers was linear at 73.2071～219.6214 μg·mL-1(r=0.999 98),and 0.5081～3.0485 μg·mL-1(r=0.999 99).The recoveries of dexlansoprazole at low,middle and high concentrations were 98.9％(RSD=0.040％),99.4％(RSD=0.42％)and 98.7％(RSD=0.89％),respectively.The recoveries of isomers at low,middle and high concentrations were 103.6％(RSD=2.3％),102.6％(RSD=2.1％)and 100.8％(RSD=0.26％),respectively.The limit of detection was 0.4928 μg·mL-1 and 0.2540 μg·mL-1;the limit of quantitative was 0.9856 μg·mL-1 and 0.5081μg·mL-1.Conclusion This method is specific and accurate for determination the content and its isomers in dexlansoprazole.
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