Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHODS FOR THE SIMULTANEOUS ESTIMATION OF RABEPRAZOLE AND DOMPERIDONE IN BULK AND DOSAGE FORM BY UV AND HPLC

Pavan Kumar.V*, V.Haribaskar, Anupam Kanti Bag and B.Kumar

ABSTRACT

A simple, rapid and precise method is developed for the quantitative simultaneous determination of Rabeprazole and Domperidone in combined pharmaceutical-dosage forms. Two methods are described for the simultaneous determination of Rabeprazole and Domperidone. The first method was based on UV-Spectrophotometric determination of two drugs using simultaneous equation method. It involves absorbance measurement at 291 nm (λmax of Rabeprazole) and 286nm (λmax of Domperidone) in 30 mM ammonium sulphate (pH 5.3): Acetonitrile (62:38 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 mcg/ml for Domperidone and 1-50 mcg/ml for Rabeprazole respectively, with regression 0.999 and 0.995 for Domperidone and Rabeprazole respectively. Recovery was in the range of 98 -102%; the value of standard deviation and %R.S.D was found to be < 2 shows high precision of the method. The second method was based on HPLC separation of the two drugs in reverse phase mode using these C18, 5μ (250 X 4.6 mm). The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2 for Rabeprazole and Domperidone), accuracy 98-102% for Rabeprazole and Domperidone and specificity, in accordance with ICH guidelines.

Keywords: RP-HPLC, UV-spectrophotometer, Rabeprazole and Domperidone.