ABSTRACT

Several spectrophotometric and HPLC methods have been reported for determination of Bilastine and Montelukast in drugs and in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and robust reversed-phase high performance liquid chromatography method was developed and validated for the determination of in Bilastine and Montelukast bulk drug and in tablet formulation. In RP-HPLC method, Methanol and Water (60:40 % v/v) was used as mobile phase, at a flow rate of 1.0 ml/min, on HPLC system containing UV- detector with Openlab EZchrome software and Agilent, poroshell C18, 150 mm X 4.6 mm ID, 5 ?m. The detection was carried out at 225 nm. The method gave suitable retention time i.e. 2.89 min for Bilastine and 6.07 min for Montelukast. The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, Linearity, accuracy, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Bilastine and Montelukast in bulkdrug and in tablet formulation.The method need regular reagents for doing analysis and also less time consuming, it can be performed routinely in industry for routine analysis of bulk and marketed product of Bilastine and Montelukast. Keywords: RP-HPLC, Bilastine, Montelukast, Validation, Analytical Method
Publication date: 01/12/2025

https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9622.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.12.9622