• Rajat Haridas Tirpude

An accurate, specific, simple, fast, and precise UV spectrophotometric method has been developed and validated for the estimation of Montelukast (MONT) and Bilastine (BILA) in pharmaceutical formulation. The UV-spectrophotometric method includes Q- ratio method (Method I), Absorbance correction method (Method II), Simultaneous equation method (Method III), Area under curve method (Method IV), and first-order derivative method (Method V), For the development of the method I, wavelengths selected ware 249nm isobestic point for MONT and BILA and 282nm for MONT and 344nm for absorbance correction method II in methanol. Developed method III wavelengths selected were 252nm and 282nm for estimation of MONT and BILA respectively while for method IV, Area under curve method (AUC) using two-wavelength in the range (279-283.8) nm and (336.6-352) nm in respectively and first-order derivative spectrum method V was obtained in methanol, wavelength selected were bilastine at 279nm zero crossing point (ZCP) for Montelukast and 282.2nm of montelukast ZCP for bilastine. These methods are linear for both drugs in the range of 10-60ug/mL for montelukast and 20-120ug/ml for bilastine in methanol. The % recovery of MONT and BILA was found near to 100%. Validation of the developed methods was carried out for their accuracy, precision, ruggedness, and robustness according to ICH guidelines. The methods were found to be precise as % RSD less than 2%. The proposed method was successfully applied for the estimation of montelukast and bilastine in bulk and commercial tablet dosage form.

Bilastine (BILA), Montelukast sodium (MONT), UV spectrophotometry, Q ratio method, Absorption Correction method, simultaneous equation method, Area under curve method, first-order derivative method.

"DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRY FOR SIMULTANEOUS DETERMINATION OF BILASTINE AND MONTELUKAST IN DRUG SUBSTANCES AND COMBINATION TABLETS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 1, page no.b261-b278, January-2024, Available :http://www.jetir.org/papers/JETIR2401130.pdf

"DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRY FOR SIMULTANEOUS DETERMINATION OF BILASTINE AND MONTELUKAST IN DRUG SUBSTANCES AND COMBINATION TABLETS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 1, page no. ppb261-b278, January-2024, Available at : http://www.jetir.org/papers/JETIR2401130.pdf