Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 95-98 Shrikrishna B. Baokar et al. 95 ISSN 0975-234X Research Journal of Pharmaceutical Dosage Forms and Technology. 5(2): March- April, 2013, 95-98 Research Article *Corresponding Author: Shrikrishna Babahari Baokar, Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandals College of Pharmacy, Malegaon (Bk.), Tal- Baramati, Dist- Pune, Maharashtra, India- 413115 Email ID - krishnabaokar@gmail.com Received on 22.12.2012 Modified on 28.02.2013 Accepted on 03.04.2013 © A&V Publication all right reserved Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin Shrikrishna B. Baokar 1 *, Sugandha V. Mulgund 2 , Nisharani S. Ranpise 3 1 Department of Pharmaceutical Chemistry, Shivnagar Vidya Prasarak Mandals College of Pharmacy, Malegaon (Bk.), Tal- Baramati, Dist- Pune, Maharashtra, India- 413115. 2 Department of Pharmaceutical Analysis, Sinhgad College of Pharmacy, Vadgaon (Bk.), Off Sinhgad Road, Pune, Maharashtra, India- 411041. 3 Department of Pharmaceutics, Sinhgad College of Pharmacy, Vadgaon (Bk.), Off Sinhgad Road, Pune, Maharashtra, India- 411041. ABSTRACT: A RP-HPLC method was developed and validated for the simultaneous estimation of Vildagliptin (VIDA) and Metformin Hydrochloride (MET) in bulk and pharmaceutical dosage form. Chromatography was carried on Warers HPLC, Lichrocart C18 column (250 x 4.60 x 5m) with mobile phase comprising of 0.05 M KH 2 PO 4 : Acetonitrile (70:30 v/v pH 3.5 with Ortho Phosphoric Acid). The flow rate was adjusted to 1.0 ml/min with UV detection at 215 nm. The retention times of VIDA and MET were found to be 6.64 and 5.18 minutes respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, ruggedness were determined according to the ICH Q2B guidelines. The detector response was linear in the range of 5-25 g/ml, 10-50 g/ml for VIDA and MET respectively. In the linearity study, the regression equation and correlation of coefficient for VIDA and MET were found to be (y = 1014x + 54.43, R2 = 0.999) and (y = 307.8x + 146.0, R2 = 0.999) respectively. The proposed method is highly sensitive, precise and accurate. Hence this method developed successfully and applied for the routine quantification of active pharmaceuticals present in the commercial formulations. KEYWORDS: Vildagliptin, Metformin, Simultaneous estimation, Hypoglycemic agents, HPLC. 1 INTRODUCTION: VIDA chemically ((s)-1-{2-(3-Hydroxyadamantan1ylamino) acetyl] pyrrolidine-2-carbonitrile;1-[(3-hydroxyadamant-1ylamino)-acetyl}- pyrrolidine-2(s)-carbonitrile) belongs to class of medicines called ‘Islet enhancers’. VIDA inhibits the inactivation of GLP-1[1,2] 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 islets of langerhans in the pancreas. VIDA has been shown to reduce hyper glycaemia in type 2 diabetes mellitus 1. Literature survey reveals that only one spectrophotometric [3], one RP-LC/MS 4 and one chromatographic[5] method for the determination of VIDA in presence of its synthetic intermediate [5]. Metformin Hydrochloride (MET) is N,N-dimethylimidodicarbon imidic diamide hydrochloride [6]. It is prescribed as an oral hypoglycemic agent, used in the management of non-insulin dependent diabetes mellitus [7].