Stability Indicating RP-HPLC Method Development and Validation for simultaneous estimation of Indacaterol and Glycopyrrolate and in Bulk and Pharmaceutical Dosage Form
Keywords:Indacaterol, Glycopyrrolate, RP-HPLC
A simple, Accurate, precise method was developed for the simultaneous estimation of the Indacaterol and Glycopyrrolate in API and pharmaceutical dosage form. Chromatogram was run through Agilent C18 (150 x 4.6 mm, 5m). Mobile phase containing Buffer 0.01N KH2PO4: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0ml/min. Buffer used in this method was 0.01N KH2PO4 buffer. Retention time of Indacaterol and Glycopyrrolate were found to be 2.285min and 2.992 min. %RSD of the Indacaterol and Glycopyrrolate were and found to be 0.3 and 0.6 respectively. %Recovery was obtained as 100.73% and 99.54% for Indacaterol and Glycopyrrolate, respectively. LOD, LOQ values obtained from regression equations of Indacaterol and Glycopyrrolate were 0.45, 1.36 and 0.19, 0.59 respectively. Regression equation of Indacaterol is y = 17065x + 3029, and y = 16589x + 4026, 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.
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