Development and validation of a novel stability indicating RP-HPLC method for simultaneous determination of aceclofenac and misoprostol in bulk and from their combined dosage form

摘要

The present work is a method development and validation for the simultaneous determination along with stability studies for the bulk and combined tablet formulation of Aceclofenac and Misoprostol by using reverse phase High performance liquid chromatography (HPLC) with isocratic elution where the stationary phase used was Luna C18 250x4.6 mm, 5μ column, mobile phase was 30:70 (v/v) acetonitrile: aqueous 0.01M triethylamine buffer (pH 2.5 adjusted with 2% v/v o-phosphoric acid) , flow rate 1 ml/minute, eluent was monitored by UV detector wavelength at 227 nm. Retention time was found to be 2.541 minutes and 3.831 minutes, correlation coefficient 0.998 and 0.999, LOD 0.125 and 0.127 nm, LOQ 0.250 and 0.255 nm for Aceclofenac and Misoprostol, respectively. Linearity range was designed 0.5-7.52 μg/ mL for Aceclofenac and 0.51-7.56 μg/mL for Misoprostol. Accuracy study revealed percentage recovery 100.1%-100.8% and 100.0%-100.4%, repeatability results in terms of relative standard deviation (%RSD) 0.21 and 0.28 for Aceclofenac and Misoprostol respectively. The developed method was validated as per ICH guideline and was found to be an ideal and optimal one for regular analysis in the laboratory.