Determination of Saxagliptin Monohydrate by Derivatization UV-Vis Spectroscopy

Specific, accurate, precise and simple UV spectrophotometric method was developed for determination of SAXA in pharmaceutical dosage form and in laboratory prepared mixtures. In this method the amplitudes of zero order spectra of the dosage form containing SAXA was measured at 578 nm respectively. The method is based on derivatization technique for making SAXA UV detectable, employing reaction of ninhydrin with primary amino group of SAXA by heating at 65?C for 30min. A purple colour product forms which is used for quantitative determination of SAXA by measuring the absorbance at 578 nm. The linearity ranges for SAXA was found to be 5 ? 25 ?gmL-1 respectively. The proposed method is validated for linearity, recovery, precision, and specificity by statistical evaluation as per ICH guidelines. The formulation excipients and additives did not interfere in their determinations. Commercial tablet formulations and laboratory prepared mixture was successfully analyzed using the developed methods.