Development and Validation of Simple Simultaneous Analysis for Indacaterol Maleate and Glycopyrronium Bromide by RP-HPLC

Abstract

Simple, Accurate, precise method was developed for the simultaneous estimation of the Indacaterol and
Glycopyrrolate in Bulk and pharmaceutical dosage form. Chromatogram was run through Kromasil C18 150 x 4.6
mm, 5. Mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 55:45 was pumped through
column at a flow rate of 1.0ml/min. Buffer used in this method was 0.1% OPA buffer Retention time of Indacaterol
and Glycopyrrolate were found to be 2.319min and 2.830 min. %RSD of the Indacaterol and Glycopyrrolate were
and found to be 0.8 and 1.1 respectively. %Recovery was obtained as 99.68% and 100.08% for Indacaterol and
Glycopyrrolate respectively. LOD, LOQ values obtained from regression equations of Indacaterol and
Glycopyrrolate were 0.60, 0.23 and 1.82, 0.70 respectively. Regression equation of Indacaterol is y = 21685x +
6734.3, and y = 21025x + 3152.8 of Glycopyrrolate. Retention times were decreased and that run time was decreased,
so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.