Validation of UV spectrophotometric method for ketoprofen multicomponent crystals with malic acid and tartaric acid

Abstract

These multicomponent crystals are formed by two chemical substances, between ketoprofen and their co-formers, which are malic acid and tartaric acid. Analysis of multicomponent crystals showed a possibility of interference between constituents. To determine interference between pure drugs and their co-formers, a validated, fast, easy, efficient, and adequate analysis method is required. This study aims to evaluate and develop an analytical method validation that is accurate, specific, and reproducible on ketoprofen multicomponent crystals using UV-Vis spectrophotometry. The study was conducted by the dissolving of phosphate buffer with 7.4 pH with the addition of ethanol co-solvent to obtain calibration curve solution. The calibration curve was analyzed for linearity, accuracy, and precision. Meanwhile, the placebo interference parameter was measured on an equimolar ratio of 1:1 between ketoprofen and co-former. Validation result on the wavelength of 260.5 nm with a range of 1-16.834 µg/mL showed the linearity of R2 = 0.999 and intercept P-value > 0.05, accuracy of Recovery = 100.652%, precision of RSD = 0.568%, and placebo interference of 0%. Based on the results of this study, the UV-Vis spectrophotometer method for ketoprofen multicomponent crystals fulfilled the validation standard.