Analytical method development and validation of sitagliptine phosphate monohydrate in pure and tablet dosage form by derivative spectroscopy.

ABSTRACT

In this study zero, first and second order derivative spectrophotometric method were developed for the estimation of sitagliptine. In zero order spectrophotometery, absorbance value was measured at 267nm. In first derivative spectrophotometry amplitudes were measured at 213nm. In second derivative spectrophotometry amplitudes were measured at 276nm. Calibration curves were linear between the concentration range of 20-60μg/ml, 20-60μg/ml and 40-80μg/ml respectively. The % RSD value is less than 2% and the recovery were near 100% for all methods. This method has been validated for linearity, accuracy and precision and found to be rapid, precise, accurate and economical and can be applied for routine estimation of sitagliptine in solid dosage form. The validation of method was carried out utilizing ICH-guidelines.