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

Anandan Kalaiselvan1,2,*, S.R. Xavier Rajarathinam1,2 and Saravanan Chandran1,2

1Research and Development Centre, Bharathiar University, Coimbatore-641 046, India

2Department of Chemistry, Sacred Heart College (Autonomous), Tirupattur-635 601, India

*Corresponding author: E-mail: adr18phd@gmail.com

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 (R2 = 0.9997) with a limit of quantification of 0.279 μg/mL for formoterol fumarate and 9-27 μg/mL (R2 = 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.

Keywords

Formoterol fumarate, Glycopyrrolate, RP-HPLC.

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