Abstract
A new green Reverse Phased-HPLC technique have been developed for the analysis of Montelukast sodium in both bulk and pharmaceutical formulations, using ethanol and sodium dihydrogen orthophosphate buffer as mobile phase in an 80:20 v/v ratio. The above method was developed and validated in accordance with ICH guidelines for linearity and range, sensitivity, recovery, precision, detection limit, quantification limit, and robustness. The results were found to be within the acceptance limits in accordance with ICH guidelines. This eco-friendly method reduces the usage of harmful organic solvents, making it a sustainable alternative in pharmaceutical analysis. Furthermore, by using the multilinear regression technique, for the assessment of Fexofenadine and Montelukast in their bulk pharmaceutical formulation, a novel, precise, and progressive spectrophotometric technique was created. The method was validated using various validation parameters and were found to be within the limits specified. This makes the method suitable for routine quality control analysis. It also demonstrates strong potential for application in stability studies and pharmacokinetic evaluations. Future research may focus on extending this green approach to other antihistaminic and anti-asthmatic drug combinations. This advancement highlights the growing importance of green analytical chemistry in modern pharmaceutical development, promoting safer, cleaner, and more sustainable laboratory practices globally.
Keywords: ICH Guideline, Multilinear Regression, Pharmaceutical Formulations, RP-HPLC, Validation.