SENSITIVE AND SELECTIVE APPROACHES FOR REAL TIME ESTIMATION OF ALOGLIPTIN BENZOATE AND METFORMIN HYDROCHLORIDE IN SYNTHETIC MIXTURE

SUMMARY Three simple, rapid, accurate, precise, reliable and economical spectrophotometric methods have been proposed for simultaneous determination of Alogliptin benzoate (ALO) and Metformin hydrochloride (MET). The proposed methods are based on absorption phenomena of both the drugs using spectrophotometric technique. The developed methods were simultaneous equation (method A), zero crossing first order derivative (method B) and Dual wavelength method (method C). All the three methods were validated according to ICH (Q2 R1) guidelines. The ranges for ALO and MET were found to be 0.1-0.5 µg/ml and 4-20 µg/ml for all the methods respectively. For method A values of limit of detection (LOD) were 0.005517µg/ml, and 0.24018 µg/ml and the values of limit of quantitation (LOQ) were 0.016717 µg/ml and 0.727823 µg/ml for ALO and MET respectively. For method B, LOD values were 0.021481 µg/ml and 0.120206 µg/ ml and LOQ values were 0.065095 µg/ml and 0.364261 µg/ml for ALO and MET, respectively. For method C, LOD values were 0.008013 µg/ml and 1.34055 µg/ml and LOQ values were 0.024283 µg/ml and 4.062272 µg/ml for ALO and MET. The precision values were less than 2% R.S.D. for all three methods. The excipients and additives which were selected did not interfere in their determinations. The results obtained by the proposed methods have been statistically compared by one way ANOVA (analysis of variance).