Abstract

METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN IN TABLETS AND DOSAGE FORM BY UV SPECTROPHOTOMETER

Ch. Anupama Swathi*, O. Krupa Santhi, V. Supriya, SK. Shakirunnisa, T. Sandhya Rani and Dr. K. Padmalatha

ABSTRACT

Current study develops and validates a simple, precise, accurate, specific and highly sensitive method for he determination of Vildagliptin in bulk and pharmaceutical dosage forms. Vildagliptin is an oral anti-hyperglycaemia agent (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs.Vildagliptin inhibits the inactivation of the GLP-1 and GIP by DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas. Vildagliptin also shown to reduce hyperglycaemia in type 2 diabetes mellitus. The solvent used is PH 6.8 Buffer and the λmax or the absorption maxima of the drug was found to be 210nm.The parameters specificity, linearity, accuracy, precision and robustness were evaluated according to international Conference on Harmonization (ICH) Guidelines. A linear response was observed in the range of 10-60μg/ml with a regression coefficient of 0.9901. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.308 and 0.934 mcg/ml respectively

Keywords: Vildagliptin, Hyperglycaemia, UV-Spectroscopy.