Abstract

BIOEQUIVALENCE OF TWO FORMULATIONS OF CEPHALEXIN IN HUMAN HEALTHY VOLUNTEERS ON (HPLC) TECHNIQUE

Alaa Kamal Jabbar Alhamd*

ABSTRACT

Cephalexin is commercially available in the form of capsules and tablets containing 250mg or 500mg for oral administration. Cephalexin is presently used as the most common antibiotics .Twenty healthy Human volunteers were characterized respected to their pharmacokinetic and bioavailability of two formulations of Cephalexin from two sources of industrial companies after a single dose administration was given orally. A developed procedure is described for determination the concentration levels of Cephalexin in human plasma of healthy volunteers using Reversed phase high performance liquid chromatography (Rp-HPLC) with ODS-C18-DB column at low wave length of UV-visible detection "254nm". An efficient drug
extraction procedure was used for the separation of cephalexin after simple extraction with cold methanol. The pharmacokinetic of Cephalexin capsule "500mg" orally administrated treatment through 6 hours has been examined. The Cephalexin was eluted for "12.0 minutes" at flow Rate "1.0 ml/min." and Temperature equal to 298oK .The retention time of Cephalexin was observed at 4.9 minutes. The mean absolute recovery of Cephalexin in blood plasma of all healthy volunteers were 98.9% at 1.0 ppm, 99.0% at 5.0ppm, 93.5% at 10.0ppm, 101.8% at 15.0ppm ,105.5% at 20ppm, 100.1% at 25 ppm, 100.0% at 30 ppm, 98.3% at 35 ppm, 95.5% at 40 ppm, 97.9% at 45 ppm and 103% at 50ppm respectively. The assay showed excellent relationships between the area underthe curve ratios and drug concentration levels (P>0.005) .Oral Cephalexin administration in twenty healthy volunteers gave maximum concentration "Tmax"peak plasma at two hours and decline through six hours. Treatment with Iraqi formulation Cephalexin capsule produced higher area under the curve "AUC" and maximum concentration "C max" of Cephalexin than Indian formulation.

Keywords: Cephalexin, Bioequivalence, Rp-HPLC, ODS -DB column.