Abstract
Amoxicillin is commercially available in the form of capsules and tablets containing 250mg or 500mg for oral administration. It is also available in the form of suspension containing "25mg/ml†. Amoxicillin is presently used as the most common antibiotics .Ten healthy Human volunteers were characterized respected to their pharmacokinetic and bioavailability of two formulations of Amoxicillin from two sources of industrial companies after a single dose administration was given orally. A procedure is described for determination the concentration levels of Amoxicillin in human plasma of healthy volunteers using high performance liquid chromatography (HPLC) with reversed-phase isocratic column at low wave length of UV-visible detection "230nm". An efficient drug extraction procedure was used for the separation of Amoxicillin after simple extraction with cold methanol using ODS-C18-DB column. The pharmacokinetic 500mg of Amoxicillin capsule orally administrated treatment through 10 hours has been examined. The Amoxicillin was eluted for "10.0 minutes" at flow Rate "1.5ml/min." and Temperature equal to 298 K .The retention time of Amoxicillin was observed at 7.0 minutes. The mean absolute recovery of Amoxicillin in blood plasma of all healthy volunteers were 94.1% at 1.0ppm, 102% at 5.0ppm, 103% at 10.0ppm 102% at 20ppm, 99.3% at 40ppm and 104% at 50ppm respectively. The assay showed excellent relationships between area under the curve ratios and drug concentration levels (P>0.002) .Oral Amoxicillin administration in ten healthy volunteers gave maximum concentration peak plasma at two hours and decline through ten hours. Treatment with Iraqi formulation Amoxicillin produced higher area under the curve “AUC†and maximum concentration “C (max)†of Amoxicillin than Indian formulation.
 Key word: Amoxicillin, Bioequivalence, ODS -DB column.
Highlights
Amoxicillin capsules and Amoxicillin suspensions were analyzed for their drug content as described in the united state pharmacopeia [1]
Amoxicillin (AMO) is oral semisynthetic penicillin structurally related to Ampicillin as shown below: The present of benzyl ring in the side chain extends the antibacterial activity to gramnegative bacteria [9]
The bioavailability of two brands of melixican (7.5mg and 15mg) tablets and to obtained pharmacokinetic parameters of this molecules on Mexican population using modified and validated high performance liquid chromatography ―HPLC‖ technique pharmacokinetic parameters AUC, C(max), and T(max) were determined from plasma concentration levels of both formulations that the results indicated in a C(max) 120% larger and T(max) 65% faster than those reported[23,24]
Summary
Amoxicillin capsules and Amoxicillin suspensions were analyzed for their drug content as described in the united state pharmacopeia [1]. The bioavailability of two brands of melixican (7.5mg and 15mg) tablets and to obtained pharmacokinetic parameters of this molecules on Mexican population using modified and validated high performance liquid chromatography ―HPLC‖ technique pharmacokinetic parameters AUC , C(max) , and T(max) were determined from plasma concentration levels of both formulations that the results indicated in a C(max) 120% larger and T(max) 65% faster than those reported[23,24]. After evaluation of the various condition of the (HPLC) assay, a suitable and simple assay for the determination of Amoxicillin in human plasma of healthy volunteers was developed using reversed-phase isocratic (HPLC) at direct low wave length of UV-visible detection (230nm) and temperature equal to 298 K for subsequent study of pharmacokinetics and bioavailability. 10mM that containing 0.1mM 1octane Sulphonic acid sodium salt: methanol (95:5) (v/v), pH buffer equal to six, column temperature 298 K, flow rate equal to (1.5ml/min.) and UV-visible detection at 230nm. The area under the curve ‖AUC‖ of the Amoxicillin concentration levels versus time from 5.0 minute to ten hours were estimated from "figure-4"
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Schedule a callMore From: Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512)
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