A validated stability indicating RP-HPLC method development and validation of for simultaneous estimation of indacaterol and glycopyrrolate in pharmaceutical dosage form

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Indacaterol and Glycopyrronium in the bulk and pharmaceutical dosage form. The chromatogram was run through Std Denali C18150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1%OPA: Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 0.8 ml/min. The buffer used in this method was 0.1% OPA buffer. The temperature was maintained at 30°C. The optimized wavelength selected was 230.0 nm. The retention time of Indacaterol and Glycopyrronium were found to 2.323min and 3.140 %RSD of the Indacaterol and Glycopyrronium were %RSD found to be 0.2% and 0.2% respectively. %Recovery was obtained as 99.39% and 99.41% for Indacaterol and Glycopyrronium respectively. LOD, LOQ values obtained from regression equations of Indacaterol and Glycopyrronium were 1.08, 3.28, and 0.25, 1.47 respectively. Regression equation of Indacaterol is y = 24501x + 7142.3, y = 26335x + 7822.7of Glycopyrronium.Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.