Development and validation of a green method for dissolution monitoring of pharmaceutical combinations: Meloxican and pridinol

Abstract

The development of a chemometric method for monitoring the pharmaceutical dissolution, under green analytical chemistry principles, was reported. Meloxicam (MEL) and pridinol (PRI) were employed as a combination model. Multivariate curve resolution with alternating least squares (MCR-ALS) was proposed to resolve UV spectra of the analytes during pharmaceutical dissolution. Empowering UV?vis spectrophotometry, which is considered an economical, ecological and fast technique, but poor in terms of selectivity. The developed method was validated in accordance to ICH guidelines, fulfilling acceptance criteria for linearity (r > 0.99 in the ranges 3.5?19.6 mg L −1 and 0.81?5.41 mg L −1 for MEL and PRI, respectively), accuracy (96.3% and 100.6% recoveries for MEL and PRI respectively), and precision (RSD < 10%) were evaluated using an independent validation set. Using a commercial sample, the method´s accuracy was evaluated against HPLC analysis. Dissolution profiles were obtained using both methods. A point-to-point comparison with Moore and Flanner´s factors (f 1 and f 2 ) were calculated. Specificity was evaluated by spectral correlation (R 2 >0.950). Additionally, the developed method works on-line and forgoes organic solvents and dilutions, lending itself to automation.