Densitometric determination of omeprazole, pantoprazole, and their impurities in pharmaceuticals

Abstract

A method has been developed for separation of omeprazole and pantoprazole, and their impurities omeprazole sulfone and N-methylpantoprazole, by HPTLC. The mobile phase chloroform-2-propanol-25% ammonia-acetonitrile, 10.8 + 1.2 + 0.3 + 4 (v/v), enables good resolution of large excesses of the drugs from the possible impurities. Regression coefficients (r > 0.998), recovery (90.7-120.0%), and detection limit (0.025-0.05%) were validated and found to be satisfactory. The methods is convenient for quantitative analysis and purity control of the compounds.