Autori: Ranetti M C, Anuta V, Mircioiu C, Hinescu Lavinia, Ionescu M, Ionica E, Ranetti A E
Editorial: 12th Congress of Balkan Military Medical Committee, p.285, 2007.
Metformin is the most used oral antidiabetic agent, especially for type 2 diabetes. It is a biguanide glucose-lowering agent, highly recommended for obese patients.
Purpose. Analytical determination of metformin for bioequivalence studies.
Materials and method. Reversed-phase mechanism with ultraviolet (UV) detection and deproteinization plasma samples were chosen for the determination of metformin.
Results. Plasma samples were deproteinisated (1:1.5v/v); vortex 1 minute, centrifuge 10 minutes at 4000rpm. The internal standard was 8ug/ml solution Sotalol in water.
HPLC method used a Kromasil 100-5 C18 column, with an isocratic elution (1.2ml/min) at 450C column temperature. The mobile phase was 20% acetonitrile and 80% phosphate buffer 0.0125M (pH = 6.0). Drug detection was made by UV at wavelenght 236nm. The calibration graphic is rectilinear between 0.05 and 5 ug/ml (r=0.9999, n=7). Detection limit (LLOQ): 0.05ug/ml. Metformin recovery from plasma samples was 76.96%.
Conclusion. By comparison with our previous method of metformin separation from plasma samples which used the derivatisation of the analyte with p-nitrobenzoyl chloride, the present HPLC method was simple, specific, sensitive and suitable in the determination of metformin in pharmacokinetic and bioavailability studies.
Cuvinte cheie: metformin, HPLC, antidiabetic, bioequivalence studies,