Comparative analysis of analytical method development and its validation for the simultaneous estimation of Bilastine and Montelukast Sodium in bulk and its tablet formulation by planar chromatography

Abstract

The development and validation of analytical methods are crucial in guaranteeing the precision, dependability, and excellence of pharmaceutical analysis. This research investigates the field of pharmaceutical chemistry by doing a comparative examination of analytical techniques for the simultaneous determination of Bilastine and Montelukast Sodium in both bulk and tablet forms. The selected method for this analysis is planar chromatography. The simplicity, specificity, precision, and accuracy of a high-performance liquid chromatography (HPTLC) approach were investigated for their use in the simultaneous estimation of the antihistaminic combination medication Bilastine and Montelukast Sodium in bulk and its pharmaceutical dose for the treatment of allergic rhinitis. Densitometric readings were taken at 254 nm after separating substances using ethyl acetate, toluene, methanol, and ammonia (7:0.5:1.5:0.5v/v/v/v) as mobile phase and precoated aluminium silica gel plates (60F254) as stationary phase. Bilastine and montelukast Sodium have Rf values 0.2 (Bilastine) & 0.4 (Montelukast Sodium), which is considered an acceptable resolution. The International Conference on Harmonization's (ICH) requirements validated the processes for accuracy, linearity, precision, robustness, and system adaptability. Bilastine and Montelukast Sodium concentrations were determined without any disruption from the excipients. Both Bilastine and Montelukast Sodium were effectively quantified using the suggested method, which bodes well for its utility in enhancing quality assurance.