Development and Validation of Simultaneous Estimation of Glycopyrrolate and Formoterol Fumarate in its Bulk and Pharmaceutical Rota Caps Dosage form by using RP-UPLC

Abstract

A new, simple, rapid, selective, precise, and accurate isocratic reverse-phase high-performance liquid Chromatography assay method has been developed for simultaneous estimation of Glycopyrrolate and Formoterol Fumarate tablet formulations. The separation was achieved by using column BEH C18 (2.6m x 50mm 1.8  m) in the mobile phase consisted of pH 2.5 triethyl amine buffer and Methanol in the ratio of 50:50 v/v. The flow rate was 0.2 mL/min, column oven temperature 25° C, the injection volume was 6 μL, and detection was performed at 250 nm using a photodiode array detector (PDA), Run time 6 minutes. The retention time of Glycopyrrolate and Formoterol Fumarate was noted to be 0.68 minutes and 1.05 minutes respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and