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CHEMICAL ASSAY AND PHARMACOKINETIC BEHAVIOUR OF FOUR BRANDS OF CHLOROQUINE TABLETS
Abstract:
The amount of active ingredient in four brands, of chloroquine tablet were determined by the chemical assay method as described in B, P, (1980) for both chloroqulne phosphate and sulphate tablets. The results (except for one brand) complied favourably with stated amount:; in the monogram for chloroquine content (92.5-107.5%). The exceptional brand was found to contain 58.31 per cent of the labelled amount of chloroquine. Pharmacokinetic behaviour of the four brands of chloroquine tablets was studied in 25 healthy adult volunteers. The H.P.L.C. assay as described by Qgunbona et al. (1986) was adapted for the estimation of plasma choloroquine concentration. Area under the plasma concentration-time curve for the firet 6 hours AUCo-sbr was calculated by the trapezoidal rule. Pharmacokinetics of chloroquine in individual volunteers was calculated from parameters generated by HKINBMPM, a modified version of SIKP as described Johnston (1985). The mean parameters determined from these data wore compared by Student t test. The absorption of all the brands was rapid with a lag time ranging from 0 to 7.3min and tmax occurring between 2,1 to 4h and omftM ranging from 111.3 to 583.1 ng/ml. There was no significant difference in the mean lag times but the cmax and AUC(0-8h) of the substandard brand differed significantly from the others. Furthermore, analysis of the AUCs revealed that none of the four brands was bioequivalent to the other during the first 8h of the study and only two could be considered to be bioequi valent at the end of the study. The data suggest that a few of the drugs in use in Bigeria may be Mfaked” and could contribute to therapeutic failures and other problems such as the emergence of resistance and dictate the need for more stringent control of the drug scene. However, the purity of the active ingredients in the brands of chloroquine used in this study is assured by the basic similarity in most pharmacokinetic parameters.
CHEMICAL ASSAY AND PHARMACOKINETIC BEHAVIOUR OF FOUR BRANDS OF CHLOROQUINE TABLETS
