Method Development and Validation of Indacaterol Maleate By RP-HPLC In Bulk and Pharmaceutical Dosage Form

A simple, sensitive and accurate RP-HPLC method has been developed for the determination of Indacaterol maleate in bulk and marketed formulation. The λmax of the Indacaterol maleate was found to be 260 nm in Methanol: water (90:10) pH 3.0. The method shows high sensitivity with linearity 10 to 50µg/ml (regression equation: y = 38835x + 278291; r² = 0.9993). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.146 µg ml –1 and 0.442 µg ml–1 respectively. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Indacaterol maleate in bulk and Table dosage form.