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

Sai Lakshmi E, Sravya E, Sireesha D, Vasudha Bakshi


A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing  methanol, Thermoscientific C18 column, (250x4.6 particle size of 5µ) at  room temperature  and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ  in accordance with ICH guidelines. 


Sitagliptin; Method development; Validation; RP-HPLC;

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