• Vatsal Suresh bhai padhiyar
• Dr. Pragnesh patani

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 (MON) and Bilastine (BIL) from its pharmaceutical dosage form. A reverse phase high performance liquid chromatographic method was developed for the Simultaneous Estimation of Montelukast Sodium (MON) and Bilastine (BIL) in Pharmaceutical Dosage Form. The separation was achieved by Hypersil ODS C18 5µ column (250 x 4.6 mm) Column and ACN: Water = 70:30 v/v as mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 215 nm. Retention time of Montelukast Sodium and Bilastine was found to be 7.374 min. and 4.819 min. respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Montelukast Sodium 10-50 μg/ml and for Bilastine 20-100 μg/ml. Developed method was found to be accurate, precise and rapid for Simultaneous estimation of Montelukast Sodium (MON) and Bilastine (BIL) in pharmaceutical dosage form.Forced degradation studies were performed under different conditions like hydrolysis, oxidation and Thermal degradation. Considerable Degradation was found in Acid degradation.The method was validated according to ICH guidelines Q2 (R1).

"Development and validation of stability indicating method for simultaneous estimation of montelukast sodium and bilastine from its pharmaceutical dosage form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.8, Issue 6, page no.b865-b877, June-2021, Available :http://www.jetir.org/papers/JETIR2106264.pdf

"Development and validation of stability indicating method for simultaneous estimation of montelukast sodium and bilastine from its pharmaceutical dosage form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.8, Issue 6, page no. ppb865-b877, June-2021, Available at : http://www.jetir.org/papers/JETIR2106264.pdf