Determination of Optical Purity of Dexlansoprazole Sustained-release Capsules by HPLC
Abstract
OBJECTIVE:To establish the method for the determination of optical purity of dexlansoprazole sustained-release capsules. METHODS:Lansoprazole was separated by using chiral column,and HPLC method was adopted for the determination.Chiralcel OZ-H column was used with mobile phase consisted of n-hexane-isopropyl alcohol(3 ∶ 1)at the flow rate of 0.7 ml/min.The determination wavelength was 284 nm and column temperature was 40 ℃. The injection volume was 20 μl. RESULTS:The linear range of dexlansoprazole were 0.096 64-0.302 mg/ml(r=0.999 9). The recoveries were 99.75%-100.02% at low,medium and high concentrations(RSD0.15%,n=3). CONCLUSIONS:The method is simple and has good recovery and prescision. It can be used for the determination of optical purity of dexlansoprazole sustained-release capsules.
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