Development and Validation of Spectrofluorimetric Method for the Estimation of Fexofenadine Hydrochiloride and Montelukast Sodium in Bulk and Pharmaceutical Dosage Form

Abstract

Accurate, sensitive and reproducible UV-spectrophotometric and spectrofluorimetric methods were developed for the simultaneous estimation of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MON) in their combined dosage form. This paper describes validated UV spectrophotometric, spectrofluorimetric methods for the simultaneous estimation of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MON) in bulk and combined tablet dosage form. UV Spectrophotometric method includes simultaneous equation method that involves measurement of absorbance at two wavelengths at 220nm (λmax of FEXO) and 344 nm (λmax of MON) in methanol. Linearity range was observed in the concentration range 1.2-60 and 0.1-5 μg/mL with R2 0.999 and 0.997, respectively for FEXO and MON. The mean recovery for FEXO and MON were found to be 100.04 % and 99.21 % respectively. LOD and LOQ were found to be 0.2166 & 0.6952 μg/mL for FEXO respectively and 0.1046 & 0.3148 μg/mL for MON respectively. spectrofluorimetric method includes synchronous spectrum method that involves measurement of fluorescence intensity at two wavelengths in synchronous spectra of drugs at 510 nm for FEXO and 400 nm for MON in methanol. Linearity range was observed in the concentration range 1-25 and 2-20 μg/mL for both drugs with R2 0.993 and 0.994, respectively for FEXO and MON. The mean recovery for FEXO and MON were found to be 99.66% and 99.98% respectively. LOD and LOQ were found to be 0.9592 & 2.9065 μg/mL for FEXO respectively and 0.2981 & 0.9035 μg/mL for MON respectively. The validation was ddone by ICH guidelines and successfully applied to marketed tablet formulation.