Analytical Method Development and Validation for the Simultaneous estimation of Alprazolam and Propranolol in their combined dosage form

Abstract

To develop and validate simple, rapid, economic and accurate spectrophotometric methods for the estimation of the Alprazolam and Propranolol which can be applied successfully for the analysis of both the drugs in pure as well as in their combined dosage form. A double-beam Shimadzu UV-Visible spectrophotometer, 1800, with a pair of 1cm matched quartz cells was used to measure the absorbance of the solutions in both developed methods viz. simultaneous equation method and absorption ratio method. 0.1N HCl was selected as solvent for the preparation of solutions. After scanning 10μg/ml solution of each drug separately in the range of 200-400 nm, wavelength of maximum absorption of ALP (262.5 nm) and PROP (288.5 nm) were selected for simultaneous equation method and isobestic point (283 nm) and absorption maxima of ALP (262.5 nm) were selected for absorption ratio method. The methods were validated statistically as per ICH guidelines. Linearity ranges from 5-25 μg/ml for both drugs. %RSD calculated was less than equal to 2 which indicates accuracy and reproducibility of the method. Recovery studies indicate that these drugs could be quantified simultaneously without interference of the excipients present in formulation. The developed UV spectroscopic methods are simple, precise, less time consuming, economical and accurate and thus are suitable for the analysis of ALP and PROP in combined dosage form.