Development and Validation of High-Performance Thin- Layer Chromatography Method for the Simultaneous Densitometric Determination of Metformin and Rosiglitazone in Tablets

Research Article

Austin J Anal Pharm Chem. 2016; 3(3): 1071.

Development and Validation of High-Performance Thin- Layer Chromatography Method for the Simultaneous Densitometric Determination of Metformin and Rosiglitazone in Tablets

Susheel JV*, Paul D and Ravi TK

Department of Pharmaceutical Analysis, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore-641044, Tamil Nadu, India

*Corresponding author: Susheel John Varghese, Department of Pharmaceutical Analysis, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore-641044, Tamil Nadu, India

Received: August 18, 2016; Accepted: September 02, 2016; Published: September 06, 2016

Abstract

This paper describes validated High-Performance thin-layer chromatography (HPTLC) method for the simultaneous determination of metformin (MET) and rosiglitazone (ROS) in combined tablet dosage forms. The HPTLC separation was carried out on aluminum backed silica gel 60F254 layers using methanoltetrahydrofuran- ammonia, 8:3:1.5 (v/v/v), as the mobile phase. Quantification was achieved with UV detection at 262nm. The developed analytical method was validated according to International Conference on Harmonization guidelines in terms of parameters like accuracy, precision, linearity, and specificity. Good linearity was observed in the concentrations ranging from 0.12 to 0.48 and 15 to 60 μg/band for ROS and MET, respectively. The recovery study results ranged from 98 to 103% for MET and ROS, showing the accuracy of the method. The method was successfully applied for the analysis of the drugs in laboratory prepared mixtures and commercial tablets. The developed method is simple, precise, and sensitive, and applicable for simultaneous determination of MET and ROS in pure powder and tablets.

Keywords: Metformin; Rosiglitazone; High-Performance Thin-Layer Chromatography (HPTLC); Densitometric determination

Introduction

Metformin hydrochloride (MET) (1-carbamimidamido-N, N-dimethylmethanimidamide) (Figure 1) is a biguanide antihyperglycemic agent used for treating non-insulin-dependent diabetes mellitus [1]. Rosiglitazone (ROS) (5-[(4-{2-[methyl (pyridin-2-yl) amino] ethoxy} phenyl) methyl]-1, 3-thiazolidine-2, 4-Dione) (Figure 1) is an anti-diabetic drug in the thiazolidinedione class of drugs [2]. Metformin hydrochloride and rosiglitazone is a combination of two oral diabetes medicines that help control blood sugar levels for people with type II diabetes who do not use daily insulin injections [3]. The complementary actions of the antidiabetic agent’s metformin hydrochloride and rosiglitazone maleate may maintain optimal glycemic control in patients with type 2 diabetes; therefore, their combined use may be indicated for patients whose diabetes is poorly controlled by metformin alone [4]. As first-line therapy in patients with uncontrolled type II diabetes, rosiglitazone/metformin fixed-dose combination therapy achieved significant reductions in A1C (glycated haemoglobin) and FPG (fasting plasma glucose) compared with either rosiglitazone or metformin monotherapy [5].