[ comparative study of optical purity of some generic and under license solid pharmaceutical products of esomeprazole using validated HPLC method]

ABSTRACT

This method was applied to perform a comparative study of optical purity of some generic solid pharmaceutical products of esomeprazole [capsules, tablets] manufactured locally and in some neighbouring 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 [7030, 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[degree]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%