Development and Validation of a Viable and User-Friendly Spectrophotometric Analytical Method for Estimation of Assay of Formoterol and Beclomethasone in Metered Dose Inhaler Formulation

Abstract

The primary aim of this research endeavor is to innovate a viable and user-friendly UV spectroscopic approach for quantifying formoterol and beclomethasone within metered dose inhalers (MDIs). These formulations, amalgamating Beclomethasone Dipropionate (BDP) and Formoterol Fumarate (FF), are extensively employed in managing bronchial asthma and chronic obstructive pulmonary diseases. Although analytical techniques already exist for assessing formoterol and beclomethasone in combination dry powder inhalers, this study concentrates on devising and validating a UV spectrophotometric method for simultaneously quantifying formoterol fumarate and Anhydrous Beclomethasone Dipropionate in Pressurized Metered Dose Inhalers (pMDIs). The estimation is performed at a wavelength of 240 nm for Beclomethasone Dipropionate and 216 nm for Formoterol Fumarate. Both drugs demonstrate satisfactory linearity within the concentration range of 10-30 μg/ml for BDP and 0.3 to 0.9 μg/ml for FF at wavelengths of 240 nm (r^2=0.999) and 216 nm (r^2=0.999), respectively. The Beer-Lambert law is adhered to within the concentration range of 10-30 μg/ml for BDP and 0.3-0.9 μg/ml for FF. The proposed methods are subjected to validation following ICH guidelines to assess accuracy, method precision, specificity, among other parameters. As a result, the proposed method can be effectively employed for the simultaneous determination of Beclomethasone Dipropionate and Formoterol Fumarate in routine analytical applications, offering a rapid and reliable solution for pharmaceutical analysis in the field.