THE ESTIMATION OF VILDAGLIPTIN IN TABLETS BY RP-HPLC.

P. Janaki Pathi*, N. Appala Raju, Tulliballi Shyam, Ch. Sowmya

ABSTRACT

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Vildagliptin in Tablets dosage form. A Inertsil ODS 3V C18, 250x4.6 mm i.d, 5 μm partical size, with mobile phase consisting of Acetonitrile and 0.03 M potassium dihydrogen phosphate in water (pH 3.5 adjusted with o-phosphoric acid) in the ratio of 80:20 v/v was used. The flow rate was 1 ml/min and the effluents were monitored at 205 nm. The retention time was 3.857 min. The detector response was linear in the concentration of 50-300 mcg/ml. The respective linear regression equation being Y= 33227.348x+101075.26. The limit of detection and limit of quantification was 0.25 and 0.75 mcg/ml respectively. The percentage assay of Vildagliptin was 98.56 %. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Vildagliptin in bulk drug and in its pharmaceutical dosage form.

Keywords: Vildagliptin, RP-HPLC, Estimation, and Tablets.