Development And Validation of Analytical Method for The Simultaneous Estimation of Montelukast Sodium and Levocitrizine Dihydrochloride by Using Quality by Design (Qbd) Approch

Abstract

The study explores the application of the Quality by Design (QbD) approach in the formulation and evaluation of Montelukast Sodium and Levocetirizine Dihydrochloride highlighting its growing significance in pharmaceutical development. QbD focuses on enhancing product quality through systematic design and includes key elements such as the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Quality Risk Management (QRM), and Design Space.

The primary objective of the research was to develop and validate a UV spectrophotometric method for the quantitative determination of these two compounds. The method underwent rigorous validation, assessing parameters like linearity, precision, accuracy, limit of detection, and limit of quantification, following ICH Q2 (R1) guidelines. The results indicated that the method is highly sensitive and accurate, making it suitable for routine analysis of tablet formulations containing Montelukast Sodium and Levocetirizine Dihydrochloride.

The study demonstrates the effectiveness of the QbD approach in pharmaceutical formulation and provides a reliable analytical method for the simultaneous estimation of the two drugs.