Simultaneous Quantification of Formoterol Fumarate and Glycopyrrolate Using Reverse Phase High Performance Liquid Chromatography

Abstract

A fully validated and rapid RP-HPLC method suitable for the quantification of formoterol fumarate and glycopyrrolate combination is reported. Chromatographic separation was achieved on a Sunsil C18 analytical column (250 mm × 4.6 mm, 5 µ particle size). The analytes were detected and quantified by photodiode array detector set at 289 nm. Calibration curves were constructed in the range of 4.8-14.4 µg/ mL (R 2 = 0.9997) with a limit of quantification of 0.279 µg/mL for formoterol fumarate and 9-27 µg/mL (R 2 = 0.9998) with a limit of quantification 0.239 µg/mL for glycopyrrolate. The method was validated aaccording to ICH guidelines. The developed and validated RP-HPLC method was sensitive, selective, robust, accurate and precise for the simultaneous estimation of formoterol fumarate and glycopyrrolate in quality control laboratories.