Development and validation of rp-hplc method for the simultaneous estimation of magaldrate and simethicone in bulk And pharmaceutical dosage form

Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Magaldrate and Simethicone in bulk and pharmaceutical formulations. Separation of Magaldrate and Simethicone was successfully achieved on a Agilent zorbax XDB C18 (150 mm×4.6 mm, 5μ) or equivalent in an isocratic mode utilizing Potassium dihydrogen phosphate (pH-4.8): Methanol (40:60) v/v at a flow rate of 1.0mL/min and eluate was monitored at 235nm, with a retention time of 1.694 and 3.234 minutes for Magaldrate and Simethicone. The developed method was validated and the response was found to be linear in the drug concentration range of 50µg/mLto150 µg/mL for Magaldrate and 50µg/mLto150µg/mL for Simethicone. The values of the slope and the correlation coefficient were found to be y=26615x+ 43142 and 0.999 for Magaldrate and y=5560x-1243 and 0.999 for Simethicone respectively. This method was found to be good percentage recovery for Magaldrate and Simethicone were found to be 100.00 and 100.31 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.