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Validated HPTLC method for simultaneous estimation of esomeprazole and domperidone in tablets

H.N.Dalindre, R.R.Thorve, P.M.Bugdane, N.R.Vekariya, S.G.Londhe

A simple, accurate and precised HPTLC method was developed and validated for determination of Esomeprazole and Domperidone in their tablet dosage form. Chromatographic studywas performed on silica gel 60 GF254 thin layer chromatographic plates using dioxane-formic acid (4:0.4 v/v) as the solvent system. The detection was carried out at 286nm. Rf values were found to be 0.21 and 0.80 for Domperidone and Esomeprazole, respectively. Regression data curve showed good linear relationship in the concentration range 800-5600 ng for Esomeprazole (Y = 2.49X + 2758.5) and 1200-8400 ng forDomperidone (Y=1.71X+ 3233.8).The percent drug estimated in tablets was found to be within range of 98-102%for both the drugs. Percent drug recoverywas performed by standard additionmethod and found to be within range of 99-101 % for both the drugs. As the method is simple, accurate, precise so it can be used for routine quality control of the said drugs. The method was validated as per ICH guidelines.