VALIDATION OF A HPLC METHOD FOR THE DETERMINATION OF CEPHALEXIN IN PLASMA DESIGNED TO BIOEQUIVALENCE STUDIES. I. PREVALIDATION.
IOSEFINA NEAGU-SLOBOZEANU1, CRISTINA MIHAELA GHICIUC2, C. MIRCIOIU3, H. SEBLANI TOUFIG4, DALIA SIMONA MIRON3, G. SARAMET3
1Biopharmacy & Pharmacol Res S.A., 23 Pitar Mos, Bucharest
2University of Medicine & Pharmacy “Gr.T.Popa” Iaşi, Faculty of Medicine, Department of Pharmacology
3University of Medicine & Pharmacy “Carol Davila” Bucharest, Faculty of Pharmacy Str. Traian Vuia 6, 70139
4UFR de Pharmacie, Université de la Mediterranée, 27 Boulevard Jean Moulin, 13385, Marseille, France

Abstract:

This paper presents the partial validation of a method for the determination of cephalexin in plasma. The method included the preparation of samples by deproteinisation, followed by HPLC chromatographic analysis with detection at 261 nm, using a C18 column with mobile phases consisting of water and acetonitrile at a flow rate of 0.6 mL/min. The method was designed to be applied in a bioequivalence study for pharmaceutical forms destined to oral administration of cephalexin. Validation of chromatographic method evaluated the accuracy, precision, selectivity, sensibility and recovery of the results obtained after the measure of analyte in samples after the separation from plasma matrix. Method was linear in the concentration range of 0.2 – 20 μg/mL, accurate and precise within the limits required for bioanalytical methods, and it was selective enough to avoid the superposition of analyte peak from the endogenous peaks. The obtained limit of quantification allows the evaluation of pharmacokinetics for a time interval corresponding to 4-5 half-time, starting from the time of maximum concentration.

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