Abstract

METHOD DEVELOPMENT AND VALIDATION OF FORCED DEGRADATION STUDIES OF VILDAGLIPIN BY USING UV SPECTROSCOPY

Doredla Narasimha Rao*,  B.Chinnappadu, D. Lakshmi Sujana, V. Sai Prasanna, B.Mallikarjuna Rao

ABSTRACT

Vildagliptin is an oral antihyperglycemic agent(anti-diabetic drug) of the new dipeptidyl peptidase-4(DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1 and GIP by DPP- 4,allowing GLP-1 and GIP to potentiation the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.The drug has maximum absorbance at 230nm.The optical characteristic of drug was found to be Beer’s law limits 1-50 μg/ml. The drug sample was analyzed by UV spectroscopy using methanol as solvent and the average content of drug present in the formulation was found to be 99.96%. The % RSD of accuracy studies was found to be 99.7±0.352. The %RSD of precision was found to be 0.0209 to 0975.The% recovery of ruggedness was found to be 99.17±0.1636 and 99.69±0.5953. The force degradation studies of Vildaglipin tablet formulation was done on Stress degradation by hydrolysis under alkaline condition by using 0.1N NaOH was found to be 5.07% for 60min, 9.95% for 90min. Stress degradation by hydrolysis under acidic condition by using 3N HCl and product degradation was found to be 9.75% for 60min and 12.79% for 90 min. Dry heat induced degradation was done by using 700c temperature was found to be 10.94% for 48 hrs. Oxidative degradation was done by using hydrogen peroxide and product degradation was found to be 2.65%for 15 min. Photolytic degradation was found to be 9.53% for 3hrs and 11.36% for 6hrs.

Keywords: Vildaglipin, UV Spectroscopy, Methanol, Forced Degradation studies.