Development and validation of an analytical method for metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations by HPLC-UV.

F Al-Rimawi

Index: Talanta 79(5) , 1368-71, (2009)

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Abstract

A simple, and stability-indicating liquid chromatographic method was developed and validated for the analysis of metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations. Liquid chromatography with a UV detector at a wavelength of 232 nm using a Nova-Pak silica column was employed in this study. Isocratic elution was employed using a mixture of ammonium dihydrogen phosphate buffer and methanol (21:79, v/v). This new method was validated in accordance with USP requirements for new methods for assay determination, which include accuracy, precision, specificity, linearity and range. The current method demonstrates good linearity over the range of 0.01-0.03 mg mL(-1) of metformin hydrochloride. The accuracy of the method is 100.4%. The precision of this method reflected by relative standard deviation of replicates is 0.30%. Validation of the same method for 1-cyanoguanidine determination was also performed according to USP requirements for quantitative determination of impurities which include accuracy, precision, linearity and range, selectivity, and limit of quantification (LOQ). Low LOQ of 1-cyanoguanidine using this method enables the detection and quantification of this impurity at low concentration.