RP-HPLC method Development and Validation studies of Ranitidine Hydrochloride and Domperidone in Tablets
Author(s): Krishnasis Chakraborty, Mubeen G, Lalitha N, Ritu Kimbahune
Abstract: This study proposes a liquid chromatography (RP-HPLC) method for quantitative analysis of the most widely prescribed combinations of Ranitidine hydrochloride, Domperidone and Magaldrate in tablet dosage form in the presence of Metronidazole as an internal standard. The chromatography was done on a C18 column (250 mm × 4.6 mm, 5 (m) as stationary phase and Methanol: Potassium dihydrogen o-phosphate (65:35 % v/v, pH 3.0 adjusted to 1% OPA) as mobile phase at a current rate of 1mL/min and measured at 227nm. Retention time was found to be 2.68min, 3.66min and 5.25min for RH, DM and MZ respectively. The assay of RH and DM in the formulation was found to be 100.33% w/w and 99.53% w/w respectively. The linearity range for RH was 3-150 µg/mL and for DM was 0.2-10 µg/mL. The developed method was validated in accordance to ICH guidelines.