Determination of Enantiomeric Purity of Esomeprazole Pharmaceutical Products using Validated HPLC Method

Order of Publishing in Issue: 
Volume :13
Issue :1
January, 2019 - March, 2019
Page No: 
Bashar Al-Sabti*, Mohamed Ammar Al Khayat,Mohamed Aamer Al-Mardini
Department of Drug Quality Control and Pharmaceutical Chemistry, Faculty of Pharmacy, University of Damascus, Syria

This method was developed to perform a comparative study of 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 S and 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 25oC.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%.

Enantiomeric Purity, Omeprazole, Esomeprazole, HPLC.

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