Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN IN BULK AND DOSAGE FORM

Jagdale Ramkrishna Raosaheb* Dabhade M. P. Kokate Shekhar Vikram, Shinde Vikas Sanjay and Shaikh Wasim Chand

ABSTRACT

Background and objective: Objective of the present analytical research work was to developed and validate RP-HPLC method for the estimation Vildagliptin in bulk and dosage form. Method & Results: The RP-HPLC method for Vildagliptin was developed using column Phenomenex C18 column (5μm, 250mm × 4.6mm) as stationary phase and Methanol: water (60:40 v/v) (pH 4.5 adjusted with OPA) as mobile phase. The mobile phase was maintained at a flow rate of 0.8 ml/min and volume of injection is 20 μl detection was carried out at 207 nm. The method was validated in accordance with ICH guidelines. Vildagliptin were found to be linear in the concentration rang of 10, 20, 30, 40, 50, and 60 μg/ml respectively. The result of % assay of marketed formulation was found as 98.65 -100.95 % for Vildagliptin respectively. Accuracy of the method was determined by performing recovery study and the result were found in the range of 99.56 -102.25 % w/w and for Vildagliptin respectively. % RSD of precision study of these drugs were found less than 2 % which indicated good precision of the developed method. Conclusion: The developed HPLC method was simple, rapid, easy, accurate and precise. So, the method can be applied successfully for the routine analysis of Vildagliptin in pharmaceutical industry.

Keywords: Vildagliptin, Methanol, OPA, RP-HPLC, Method Development, Validation.