ABSTRACT

Background: By considering the current regulatory requirement for an analytical method, it was optimized using analytical QbD approach and the method was validated to be simple, precise, accurate and robust in terms of change of chromatographic and technical variables in combination approved to manage Asthma and allergic conditions. Objective: To establish a RP-HPLC approach for the synchronized analysis of Montelukast Sodium (MNT) and Bilastine (BST) in Tablet Dosage Form Study Design: Quality by design-based method development was done using “Design Expert ® (Version 13)” and its validation was performed as recommended in “ICH guideline”. Materials and methods: Method develop with chromatographic parameters as C18 column Inertsil ODS (150 * 4.6mm, 5µm), HPLC system with PDA detector with 0.05M KH2PO4 Buffer: Acetonitrile (65:35 % v/v) mobile phase & 1.0 mL/min flow rate and detected at 280 nm. QbD approach was applied to estimate the effect of two factors i.e., mobile phase composition and flow rate on the innumerable chromatographic responses. Results: The perfect sharp peak observed at Retention time of BST and MNT were 3.367 and 6.314 min respectively. It was showed linear calibration curve in the quantity range 10-30 ?g/mL and 5-15 ?g/mL. %Assay of drugs was 100.67% and 99.67% for BST & MNT. Conclusion: Developed method was found to be accurate, precise and rapid for simultaneous estimation of BST and MNT in tablet. Keywords: Bilastine and Montelukast sodium, RP-HPLC-PDA System, QbD Approach, Validation
Publication date: 01/11/2022

https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6608.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.11.6608