COMPARATIVE IN VITRO BIOEQUIVALENCE EVALUATION OF SIX BRANDS OF AMOXICILLIN CAPSULE MARKETED IN DUTSE, JIGAWA STATE, NIGERIA
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ABSTRACT
Comparative in vitro bioequivalence study of biopharmaceutics class I and III drugs hadgained prominence in recent times. In vitro bioequivalence offered many benefits compared to conventional in-vivobioequivalence studies, due to its reduced cost and time of product release as well as avoiding unnecessary use of human volunteers.This study is aimedat evaluating and comparing the in vitro bioequivalence of branded and generic amoxicillin capsules available in Dutse, Jigawa State,Nigeria.Thesamples were randomly selected and evaluated for quality control studies via BP 2009 and USP 2009 specifications.Four UVSpectrophotometry methods for thedetermination of amoxicillin in simulated physiological media (pH 1.2, 4.5, 6.8, and 7.4), were developed and validated according to ICH guideline. Dissolution testing was conducted using USP apparatus I, sink volume of 900 ml, temperature 37± 0.5 oC and 100 rpm, samples were withdrawn at an interval of 5, 15, 25, 35 and 45 minutes respectively. Bioequivalence of the samples were compared using different statistical methods; the difference factor (f1), similarity factor (f2) and the dissolution efficiency (% D.E.). From the result of quality control studies, all the brands were found to passed identification test as their IR spectra were superimposable with reference amoxicillin spectrum. Four of the six brands (A, B, C and E) passed the assay test,(90-120) USP 2009 while,brands D and F failed. The uniformity of weight test all the brands passed with percentage mean deviation <7.5% (BP 2009).All the brands disintegrated in less than 15 minutes as required by BP 2009.The four methods developed for the determination of amoxicillin have λmax. 229nm for buffer solutions(pH 1.2 and 4.5) and 228nm for (pH 6.8 and 7.4).The calibration curves were linear at the concentration range of 10-60 μg/mltheir correlation co-efficientwere 0.999, vi 0.997, 0.997 and 0.996 for buffer solutions (pH 1.2, 4.5, 6.8 and 7.4) respectively. A regression equation of y= 0.0133x+0.1847, y=0.0137x+0.1967, y=0.0143x+0.2113, and y=0.0162x+0.0807for (pH 1.2, 4.5, 6.8 and 7.4) respectively. The percentage recoveries of the developed methods were within the official range of 98-102%. Likewise, the intraday and inter-day precision were within normal range of co-efficient of variation<15% (2.05% ,3.46%,2.48% ,0.66% and 9.15%,9.00%,5.82%,0.66%) for the simulated media(pH1.2,4.5, 6.8 and 7.4) respectively. The dissolution profiles obtained for each medium was subjected to bioequivalence comparison. The result of f1 for brands B and E were similar and within the acceptable range of ≤15 in each pHs. Similarly, the f2 values were ≥50 in pH 1.2 and 4.5 for B and pH 4.5 for E while in pH 6.8 and 7.4 for B and pH 1.2, 6.8 and 7.4 for E were below the acceptable range thus, failed f2 test. Also the % D.E. values of each of the simulated pHs for brands B and E were within the acceptable limit of ±10 %. So, from the result they are consideredbioequivalent with A. While, brands C, D and F failed both f1, f2 and % D. E. comparison as their values were outside the accepted range. Also, the analysis of variance (ANOVA) and dunnett multiple comparisonresultsfurther, confirmed the observed difference among the brands obtained using f1, f2 and % D.E methods at (p<0.05).Therefore, brands C, D and F, are not bioequivalent with A. About 60 % of the samples may not be considered bioequivalent with innovator (A).
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