Original Article A VALIDATED STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM N. MADANA GOPAL 1* , C. SRIDHAR 2 1 Research Scholar, Rayalaseema University, Kurnool. Andhra Pradesh, India, 2 Department of Pharmaceutical Analysis, Sri Padmavathi School of Pharmacy, Tirupathi, Andhra Pradesh, India Email: madanapharma@gmail.com Received: 02 Feb 2017, Revised and Accepted: 17 Apr 2017 ABSTRACT Objective: To develop a simple, precise, accurate, method was developed and validated for analysis of metformin hydrochloride (MET) and empagliflozin in (EMPA) in bulk and tablet dosage form. Methods: The method used a reverse phase column, dikma C18 (50×2.1 mm, 1.8 μ), a mobile phase comprising of phosphate buffer (pH-3): methanol (30:70 v/v) flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a photodiode array detector. The proposed method was validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, stability studies, formulation analysis as per International Conference on Harmonization (ICH) guidelines. Results: The retention time was found to be 1.189 min and 1.712 min for MET and EMPA respectively. The proposed method was found to be having linearity in the concentration range of 500-2500 μg/ml for MET (r 2 =0.989) and 5-25 μg/ml for EMPA (r 2 =0.994), respectively. The mean % recoveries obtained were found to be 100.35-100.48% for MET and 99.80-101.30% for EMPA respectively. Stress testing which covered acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to International Conference on Harmonization (ICH) guidelines. Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET and EMPA in bulk and combined tablet dosage form and in the routine quality control analysis. Keywords: Empagliflozin, Metformin hydrochloride, Reversed-phase ultra-performance liquid chromatography, Validation © 2017 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ijap.2017v9i3.17441 INTRODUCTION Metformin (MET) hydrochloride is chemically named as (3-(diamino methylidene)-1, 1-dimethylguanidine hydrochloride. It has a molecular formula of C4H12ClN5 and the molecular weight is 165.62 g/mol. MET is an oral anti-hyperglycemic agent (Type 2 diabetes) belongs to a class of biguanides and useful for treating non-insulin dependent diabetes mellitus. MET decreases blood glucose levels by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. These effects are mediated by the initial activation by MET of AMP-activated protein kinase, a liver enzyme that plays an important role in insulin signaling, whole body energy balance, and the metabolism of glucose and fats [1-5]. Empagliflozin (EMPA) is chemically named as 1-chloro-4-[b-D- glucopyranos-1-yl]-2-[4-([S]-tetrahydrofuran–3–yl-oxy) benzyl]- benzene (fig. 2). It has a molecular formula of C23H27ClO7 and molecular weight is 450.912 g/mol. Empagliflozin is an orally administered selective sodium glucose cotransporter-2 (SGLT-2) inhibitor, which lowers blood glucose in people with type 2 diabetes by blocking the reabsorption of glucose in the kidneys and promoting the excretion of excess glucose in the urine [6, 8]. The sodium glucose cotransporter 2 (SGLT2), located in the proximal tubule of the nephron, is estimated to facilitate-90% of this reabsorption [9, 10]. It is a potent and selective competitive inhibitor of the SGLT2 protein. Sodium-glucose co-transporter 2 (SGLT2) inhibitors offer an insulin-independent mechanism for improving blood glucose levels since they promote urinary glucose excretion (UGE) by inhibiting glucose reabsorption in the kidney. In addition to glucose control, SGLT2 inhibitors are associated with weight loss and blood pressure reductions and do not increase the risk of hypoglycemia [9]. Fig. 1: Metformin (MET) hydrochloride structure from pub chem Fig. 2: Empagliflozin (EMPA) structure from pubchem International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 9, Issue 3, 2017