VALIDATION OF A HPLC METHOD FOR THE DETERMINATION OF CEPHALEXIN IN PLASMA, DESIGNED FOR BIOEQUIVALENCE STUDIES. II. METHODS FOR THE EVALUATION OF BIOEQUIVALENCE .
IOSEFINA NEAGU-SLOBOZEANU1, CRISTINA MIHAELA GHICIUC2, C. MIRCIOIU3, H. SEBLANI TOUFIG4, DALIA SIMONA MIRON3, GABRIEL ŞARAMET3
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:

The development of a new analytical method for bioequivalence studies has to consider the interaction between analyte and biological matrix. The aim of the study was to apply different methods for the evaluation of bioequivalence of some pharmaceutical forms containing cephalexin, in the case of difficulties due to the apparition of endogenous peaks during HPLC analysis. The biological samples from bioequivalence unidose, cross-over studies with cephalexin were taken up from healthy volunteers in fasting and postprandial conditions. Many endogenous peaks appeared into real samples, unlike plasma spiked samples used for prevalidation. There were used the following methods for passing over these difficulties: the modification of the quantification limit, the modification of the time interval for the evaluation of concentration and changes in the calculation algorithm of peak area from chromatogram in order to obtain a suitable evaluation of bioequivalence

.

Top