Visible Spectrophotometric Methods for Estimation of Montelukast Sodium in Bulk Dosage forms and Formulations

Sophisticated analytical methods viz. HPLC and HPTLC which are being employed for analysis are relatively expensive and hence need for simple analytical methods arises, that are suggested in the proposed methods for routine determination of Montelukast sodium ( MTK)1,2 in pharmaceutical formulations and bulk dosage forms. These methods are based on the formation of colored species on binding of Motelukast Sodium (MTK) with ferric chloride and Concentrated. Hydrochloric acid reagents to produce a yellowish green colored chromogen (lmax at 440 nm) for method A and orcinol in Conc. HCl to produce a green colored chromogen (lmax at 420 nm) for Method B. Results of analysis were validated statistically and by recovery studies. Assay and recovery studies were also performed. The percent Relative Standard Deviation of these methods were found to be 1.32 for Method A and 0.35 for Method B. Based on these values these methods could be treated as simple, sensitive and reproducible based on the principle of absorption visible spectrophotmetry for the determination of Motelukast Sodium (MTK) in bulk and pharmaceutical formulations.