Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Bulk and Its Tablet Dosage Form

I. Arulraj¹, P. Vembu² and A. Chenthilnathan^1*
1Department of Pharmaceutical Chemistry, Manonmaniam Sundaranar University, Tirunelveli – 627 012, Tamil Nadu, India.
²Bafna Pharmaceuticals Limited, Grantlyon village, Chennai – 600 052, Tamil Nadu, India.

A B S T R A C T
A simple and sensitive reversed-phase liquid chromatographic method has been developed and validated for the estimation of Sitagliptin phosphate in bulk and its tablet dosage form. The separation was carried out on Phenomenex C18 (2) Luna coloum (250 × 4.6mm; 5µm) column at ambient temperature using buffer, 0.1 % perchoric acid in water and acetonitrile (60:40) as eluent. The flow rate was 1.0 ml/min and Sitagliptin phosphate was quantified by absorbance at 210 nm. The retention time of Sitagliptin phosphate was 4.42 min. The percentage recovery was within the range between 99.14 % and 101.3 % for Sitagliptin phosphate. The linear ranges were found in the range of 50µg/ml – 150µg/ml (r² = 0.984) of Sitagliptin phosphate. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. Hence, the proposed method could be successfully employed for routine analysis of Sitagliptin phosphate in pharmaceutical formulations according to ICH guidelines. 
Keywords: Sitagliptin phosphate, RP-HPLC, Tablets, Estimation, Validation