Smart Spectrophotometric Methods Based on Feasible Mathematical Processing and Classical Chemometry for The Simultaneous Assay of Alcaftadine and Ketorolac in Their Recently Approved Pharmaceutical Formulation.

Abstract

Alcaftadine (ALC) and Ketorolac tromethamine (KET) binary combination is a new co-formulated pharmaceutical product that is used to treat allergic conjunctivitis. The present work utilizes three simple, precise, accurate, and rapid spectrophotometric and chemometric methods to determine the recently released pharmaceutical formulation. The methods include the first derivative of absorbance spectrum (Method A), dual-wavelength (Method B), and absorbance subtraction methods (Method C). ICH guidelines have been used to validate the developed methods. Linear regression lines were found over the concentration range of 1-9 and 1-12 μg mL-1, 1-8 and 2-10 μg mL-1, and 2-10 and 2-10 μg mL-1 of ALC and KET for methods A, B, and C respectively. All the methods showed correlation coefficients higher than 0.999, in addition to low LOQ and LOD which indicate high sensitivity of the proposed methods.