Synchronous Estimation of Glycopyrrolate and Formoterol in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method

  Objective: The objective is to develop and validate a fundamental, specific, novel and exact RP-HPLC (Reverse phase-High performance Liquid chromatography) methodology for the synchronous determination of Glycopyrrolate and Formoterol in pharmaceutical dosage form. Methods and Materials: The column utilized was BDS C18 (250mm x 4.6 mm, 5µm) in isocratic mode, with mobile phase consist of phosphate buffer and acetonitrile (40:60 v/v). The buffer was made by adding 1 ml of Orthophosphoric acid in a 1000ml of volumetric flask and about 900ml of milli-Q water, degas to sonicate and lastly make up the quantity with water. The flow rate used was 1.0ml/ min and effluents were monitored at 241 nm. Results: The retention times of Glycopyrrolate and Formoterol are 2.290 min and 2.853 min, respectively. The linearity for Glycopyrrolate and Formoterol are 2.25-13.5µg/ml and 1.2-7.2µg/ml respectively. The recoveries of Glycopyrrolate and Formoterol were observed to be 99.17 to 100.66% and 98.36 to 100.79% respectively. Conclusion: The validation was performed for the proposed method and applied successfully for the determination of Glycopyrrolate and Formoterol. The method was found to be precise, accurate for the synchronous determination of Glycopyrrolate and Formoterol in pharmaceutical dosage form.