A STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF VILDAGLIPTIN AS BULK DRUG AND FROM ITS PHARMACEUTICAL DOSAGE FORM

Vildagliptin chemically (S)-1-[N-(3-hydroxy-1- adamantyl) glycyl] pyrrolidine-2-carbonitrile, is a potent dipeptidyl peptidase IV (dip-IV) inhibitor, a drug for the treatment of diabetes. DPP-IV inhibitors represent a new class of oral antihyperglycemic agents to treat patients with type 2 diabetes. The Present work describes the development and validation of a new simple, accurate, precise and stability-indicating HPTLC method for the determination of Vildagliptin in the tablet dosage form. The chromatographic separation was achieved by using Chloroform: n-Butanol: Methanol (5:2:3 v/v/v) as mobile phase and UV detection at 227nm. The developed method was validated with respect to linearity, accuracy, precision, the limit of detection, the limit of quantitation and robustness as per ICH guidelines. The described method was linear over a concentration range of 2000-20000 ng/ml for the assay of Vildagliptin. The assay was found to be 99.8%. The limit of detection (LOD) and the limit of quantification (LOQ) for Vildagliptin was found to be 357.31 ng/band and 1082.76 ng/band respectively. The drug was subjected to stress conditions of acid hydrolysis, alkali hydrolysis, photolysis, thermal degradation. Results found to be linear in the concentration range of 2000-20,000 ng/band. The proposed stability-indicating method can be used for the determination of vildagliptin in bulk samples and in the pharmaceutical dosage form.