LAUSR

BACKGROUND The concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to the literature review, no UV-visible spectrophotometry method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosage forms. OBJECTIVES Hence, five different multicomponent spectrophotometric methods were developed and validated for simultaneous estimation of montelukast sodium and bilastine using risk assessment-based enhanced analytical quality by design approach. METHODS The method risk parameters identification and assessment were done by the RPN ranking and filtering method according to the ICH Q9 guideline. The wavelength for detections and solvents such as 0.1 N NaOH and 0.1 N HCl were found critical method parameters for the development of target methods. The developed methods were validated as per ICH Q2 (R1) guidelines. RESULTS The developed and validated methods were applied for the assay of combined pharmaceutical dosage forms of montelukast sodium and bilastine and results were found in good agreement with their labelled claim. CONCLUSION The developed method did not include the usage of any organic solvent and a good alternative to the costly chromatography method. Hence, methods are eco-friendly and economical for the said estimation of bilastine and montelukast sodium. HIGHLIGHTS Development of five multicomponent spectrophotometric methods for simultaneous estimation of montelukast sodium and bilastine using risk-based AQbD approach. Assay of combined tablet dosage forms of montelukast sodium and bilastine using developed methods.