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Analytical Method Development and Validation of Sitagliptine Phosphate Monohydrate in Pure and Tablet Dosage Form by UV-Vis Spectroscopy

G Jeyabalan and Narendra Nyola

A simple, rapid and accurate spectrophotometric method was developed for the determination of sitagliptine in pure and tablet dosage form. The proposed method is based on the principle that sitagliptine exhibiting an absorption spectra of wavelength maxima 267 nm. This method has successfully used for the analysis of drug in marketed preparations in the range of 20-60 μg/ml with correlation coefficient of 0.991. The percentage recovery was found to be 99.62-100.48%. LOD and LOQ were found to be 6.03 and 18.28 μg/ml respectively. 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.