Development and Validation of a Stability Indicating HPLC Method for the Simultaneous Analysis of Esomeprazole and Itopride in Bulk and In Capsules

Abstract

A rapid, simple, selective, precise, and accurate stability indicating HPLC method has been developed and validated for the simultaneous analysis of esomeprazole and itopride in bulk and in capsule form. An isocratic separation was achieved using a Hypersil C4 (250 x 4.6 mm), 5 μm particle size column with a flow rate of 1 mL/min and photodiode array detector at 272 nm. The mobile phase consisted of 0.1M dipotassium hydrogen phosphate: acetonitrile (40:60 v/v). The method was validated for selectivity, specificity, linearity, precision, accuracy and robustness. The selectivity of the method was determined by assessing interference from the placebo, components of mobile phase and common excipients in pharmaceutical formulations. Whereas, specificity was established by stress degradation studies. The method was linear over the concentration range 40 – 120 μg/mL (R 2 = 0.9999) and 150-450 μg/mL (R 2 = 0.9999) for esomeprazole and itopride, respectively. Limit of detection is 0.207 and 0.724 μg/mL & Limit of quantitation is 0.691 and 2.415 μg/mL for esomeprazole and itopride, respectively. The precision and accuracy of the method was found to be acceptable. The method was found to be robust and suitable for the simultaneous analysis of esomeprazole and itopride in a capsule formulation. Degradation products resulting from the stress studies did not interfere with the detection and quantification of esomeprazole and itopride. The proposed HPLC method is thus stability-indicating.