Determination of enantiomeric purity of esomeprazole pharmaceutical products using validated HPLC method
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This method was developed to determine the enantiomeric purity of some products of esomeprazole (capsules, tablets) manufactured locally and in some neighboring countries for the determination the percentage of R enantiomer. A product of under license company was used for comparison of the results. The study was performed by using a validated HPLC method on chiral column Nucleocel Alpha Sand a mixture ethanol: hexane (70:30, v/v) as a mobile phase, the flow rate was 0.65 ml/min, and the detection was carried out using UV detector at 302nm. The temperature of column was set at 25◦C. The study showed that some samples were not polluted with R enantiomer, while the others contained this enantiomer in the range of 0.1-2.24%.
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Journal of Drug Designing: Open Access