Abstract

DEVELOPMENT & VALIDATION OF STABILITY INDICATING RPHPLC METHOD FOR DETERMINATION OF RELATED SUBSTANCE OF BILASTINE & MONTELUKAST IN SUSPENSION DOSAGE FORM

*Akanksha, Shivali Singla, Sujit Dana, Priyankul Palia and Sachin Goyal

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Abstract

A simple, precise and accurate newly developed and validated method for Stability Indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Simultaneous Estimation of Montelukast Sodium and Bilastine from its suspension dosage form. A reverse phase high performance liquid chromatographic method was developed for the determination of Related substance for Montelukast Sodium and Bilastine in suspension Dosage Form. The separation was achieved by Hypersil BDS C18 5μ column (150 x 4.6 mm) Column and Buffer: Acetonitrile as mobile phase, at a flow rate of 1.0 ml/min. Detection was carried out at 215 nm. Retention time of Montelukast Sodium and Bilastine was found to be 20 min. and 12 min. respectively. Sulfoxide impurity & styrene impurity are known impurities in Montelukast sodium while N-Oxide impurity & Hydroxy impurity are known impurities in Bilastine. The RS method has been validated for linearity, accuracy and precision. Developed method was found to be accurate, precise and rapid for Simultaneous Related substance detection in Montelukast Sodium and Bilastine in suspension dosage form. The method was validated according to ICH guidelines Q2 (R1).

Keywords: Analytical Method Development, Analytical Method Validation (AMV), High Performance Liquid Chromatography (HPLC), Stability Indicating Method, Bilastine, Montelukast Sodium.