Quantification of antibiotics in multicomponent drug formulations using UV–Vis spectrometer with PLS and MCR-ALS

Abstract

This study explores the potential of spectroscopic analysis combined with Partial Least Squares Regression (PLS) and Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) for the simultaneous quantification of antibiotics in multicomponent drug formulations, specifically clofazimine (CLZ) and dapsone (DAP). The analysis also evaluated the in vitro release profile of the drugs in a fixed-dose combination tablet. High-Performance Liquid Chromatography with Photodiode Array Detection (HPLC-PDA) was used as a reference analytical technique to validate and compare the chemometric models. Both PLS and MCR-ALS models demonstrated high accuracy, with MCR-ALS showing superior predictive capability for CLZ, while both models presented similar performance for DAP quantification. Notably, the results from both models were consistent with the dissolution profile, indicating no statistically significant differences between the spectroscopic and chromatographic quantification methods. Furthermore, the dissolution profile confirmed the immediate release of both active pharmaceutical ingredients (APIs), with no statistically significant differences between the spectroscopic and chromatographic quantification methods. This study highlights the efficiency and versatility of chemometric techniques as an alternative to conventional methods in the quality assessment of anti-leprosy medications.