Development and Validation of Uv Spectroscopic Method for the Determination of Metformin Hydrochloride in Tablet Dosage Form

A simple, economic, sensitive, precise and accurate UV spectrophotometric method was developed and validated for quantification of Metformin hydrochloride in bulk and in tablet dosage form. Adequate drug solubility and maximum assay sensitivity was found in 0.01N sodium hydroxide at 233nm. Calibration graph constructed at 233nm was linear in concentration range of 1-25μg/ml with correlation coefficient of 0.9998. The method was validated as per ICH guidelines in terms of linearity (within 1-25μg/ml), accuracy (% recovery), precision (inter-day and intraday), specificity and robustness. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.2226μg/ml and 0.6745μg/ml respectively. Therefore, the proposed method is suitable and can be adopted for the determination of Metformin hydrochloride from pharmaceutical dosage form in routine quality control analysis. INTRODUCTION: Metformin hydrochloride (MET) is a biguanide class of oral antidiabetic drug or blood glucose lowering agent, chemically is N, N-dimethyl imidodicarbonimidic diamide hydrochloride (Figure 1) . Metformin, itself produces the antidiabetic effect, but its hydrochloride salt is used as the salt form is more soluble in aqueous medium. It is the first line drug for the treatment of type II diabetes or noninsulin dependent diabetes mellitus (NIDDM), particularly in overweight and obese people and those with normal kidney function 7, 8 and evidence suggests it may be the best choice for people with heart failure . It is also used in the treatment of polycystic ovary syndrome. Its therapeutic effect is achieved without raising insulin concentrations, and it appears to reduce insulin resistance. Unlike the other major blood glucose lowering agents, namely suphonylurea and insulin, MET does not cause weight gain. Indeed, MET may produce a small decrease in body weight during the initial months of treatment. This cannot be attributed to a chronic decrease in food consumption or increased physical activity, suggesting that the drug increases metabolic energy expenditure. The drug is found official in Merck index . There are various spectrophotometric methods developed for estimation of MET . Solvents used for the methods are comparatively of high cost. There is a need for a simple, rapid, cost effective and reproducible method for assay of MET in pharmaceutical dosage forms.