Method Development and Validation of Magaldrate and simethicone by RP HPLC Method

Abstract

A simple, accurate, economical, rapid, selective, reverse phase high performance liquid chromatography (RPHPLC) was developed for simultaneous estimation of Magaldrate andSimethicone in its bulk dosage form. The separation was carried out using a mobile phase of Triethylamine buffer and acetonitrile(50:50) pumped at a flow rate of 1 ml/min along with 227nm as a UV detection wavelength. The stationary phase used wasInertsil ODS 3V column,C18(150x4.6 ID) 5µm. Magaldrate andSimethicone were eluted at a retention time of about 2.483 min for Magaldrate and 3.710 min for Simethicone. The method was developed and validated as per ICH guidelines by considering the parameters such as precision, accuracy, linearity, specificity, robustness and ruggedness. Linearity was 0.9963 for Magaldrate and 0.9989 for Simethicone.the %RSD was less than 2%. The % recovery of Magaldrate was100.17 and Simethicone was 100.61. The developed RP-HPLC method can be used for routine analysis of Magaldrate andSimethicone in combinational dosage form.