Damam Vidya*, B.V. Ramana, G. Nagarajan
Dr. K.V. Subba Reddy Institute of Pharmacy, Kunrool, Andhra Pradesh, India
A B S T R A C T
The present research work mainly focused on method development and validation for the simultaneous estimation of Glycopyrrolate and Formeterol fumarate in tablet dosage form by using RP-HPLC. Chromatographic separation was achieved on Xterrra C18 column (4.6*150mm, 5µ) and it maintained flow rate was 1.0 ml/min. The mobile phase consist of 0.1% OPA buffer pH 3.0 was adjusted with sodium hydroxide and methanol with the ratio of 40:60%v/v, then UV spectrum was monitored at 220nm. The retention time was found to be 4.268 min for Glycopyrrolate and 3.129 min for Formeterol fumarate. The method shows linear response in the range of concentration was 4.8-24 µg/ml for Glycopyrrolate and 9.45µg/ml for Formeterol fumarate respectively. The developed method was stastically validated according to ICH guidelines. The validation parameters are present in within the limit. So, the developed method was simple, precise, accurate and robust. It can be suggest that routine quality control analysis of analytical laboratories.
Keywords: Glycopyrrolate, Formeterol fumarate, Mobile phase, Validation, ICH guidelines