Smart UV Spectrophotometric Method for the Simultaneous Determination of Loratadine and Pseudoephedrine in Tablets

Abstract

A simple, accurate, and precise spectrophotometric method has been developed for the simultaneous determination of pseudoephedrine (PSE) and loratadine (LOR) in bulk and tablets. The method principally exploits the spectral characteristics of the two compounds to affect mathematical manipulation of Beer’s law. The approach in this method enabled the removal of the spectral interference from LOR at the wavelength for the determination of PSE. It was possible to determine pseudoephedrine in the presence of loratadine using two wavelengths (257 and 280 nm). Two calibration curves were established for the analysis. The first was constructed to quantify LOR in the mixture on the basis of its absorbance at 280 nm. The second calibration curve was developed to determine the concentration ratio (CR) between the components at 257 nm. This curve was obtained by plotting the absorbance ratio (AR) against the concentration ratio, defined as CR = [PSE]/[LOR]. The concentration of PSE was calculated using the equation: [PSE] = CR_EXP × [LOR]. The developed analytical method was statistically validated in accordance with ICH Q2 guidelines and yielded satisfactory results. The assay results, expressed as a percentage of the labeled claim, were found to be 99.97 ± 0.71% and 101.10 ± 1.32% for PSE and LOR, respectively. These findings demonstrate that the proposed method is suitable for routine quality control analysis of tablet formulations. The validity of the proposed method was confirmed through statistical comparison of the data with those obtained by a reference chromatographic method.