APPLICATION MEAN CENTERING RATIO SPECTRA METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, AND PSEUDOEPHEDRINE HCl IN TABLET PREPARATIONS

Abstract

Objective: The aim of this research is to apply the mean Centering Ratio Spectra (MCRS) method for a ternary mixture of Dextromethorphan Hydrobromide (DE), Doxylamine Succinate (DO), and Pseudoephedrine Hydrochloride (PS) in tablet preparations. Methods: The absorption spectra of DE (40-430 μg/ml), DO (20-430 μg/ml), and PS (230-630 μg/ml) were scanned in the 200-400 nm range. DE determination involved dividing DE spectra by PS (430 μg/ml) and mean-centered the ratio spectra. DO spectra were divided by DE (40 μg/ml) to obtain mean-centered ratio spectra. The mean-centered ratio spectra for PS were obtained by dividing the scanned spectra of its prepared solutions by the standard spectrum of DE, which had a concentration of 70 μg/ml. Results: Method validation parameters, including linearity, accuracy, precision, limit of Detection (LOD), and limit of Quantification (LOQ), were assessed. The results indicated linearity values of 0.9988, 0.9992, and 0.9998, respectively, for DE, DO, and PS. Accuracy: 99.84%, 100.15%, and 100.33%, respectively, for DE, DO, and PS. Precision: 0.53%, 0.54%, and 0.74%, respectively, for DE, DO, and PS. lOD: 1.85 μg/ml, 2.09 μg/ml, and 1.56 μg/ml, respectively, for DE, DO, and PS. lOQ: 6.19 μg/ml, 6.97 μg/ml, and 5.22 μg/ml, respectively, for DE, DO, and PS. All validation method parameters meet International Conference of Harmonization (ICH) validation requirements. Conclusion: The MCRS method can be applied for the simultaneous ternary mixtures of DE, DO, and PS in tablet preparations. Its successful application, combined with rigorous validation results, suggests its potential for adoption in routine pharmaceutical analysis, contributing to the advancement of quality control practices in the industry.