Development and validation of uv-vis specctroscopy method for simultaneous estimation of saxagliptin hydrochloride and metformin hydrochloride in active pharmaceutical ingrident

Journal of Pharmaceutical Education Research 12/2012; 3(2):19-23.


An analytical method for estimation of Saxagliptin and Metformin in active pharmaceutical ingrident.The method
was validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation. The
optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) of Saxagliptin
and Metformin were found to be 274 nm and 231 nm respectively. The percentage recovery of Saxagliptin and
Metformin were 100.1 and 99.98 respectively. Beer’s laws were obeyed in the concentration range 50-90μg/ml for
Saxagliptin and 2-10μg/ml for Metformin. The linear equation for Saxagliptin and Metformin were found to be
y = 0.012x- 0.462, r² = 0.987 and y = 0.055x - 0.031, r² = 0.990 respectively. Validation was performed as per ICH