CHEMICAL ASSAY AND PHARMACOKINETIC BEHAVIOUR OF FOUR BRANDS OF CHLOROQUINE TABLETS
CHEMICAL ASSAY AND PHARMACOKINETIC BEHAVIOUR OF FOUR BRANDS OF CHLOROQUINE TABLETS
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Date
1988-12
Authors
EWESUEDO, REGINALD BOWIE EJIAGU
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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.
Description
A THESIS SUBMITTED TO THE POSTGRADUATE SCHOOL
AHMADU BELLO UNIVERSITY, ZARIA, IN PARTIAL
FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF
THE DEGREE OF MASTER OF SCIENCE IN PHARMACOLOGY
DEPARTMENT OF PHARMACOLOGY AND CLINICAL PHARMACY
FACULTY OF PHARMACEUTICAL SCIENCES AHMADU BELLO
UNIVERSITY ZARIA
DECEMBER, 1988
Keywords
CHEMICAL,, ASSAY., PHARMACOKINETIC,, BEHAVIOUR,, FOUR,, BRANDS,, CHLOROQUINE,, TABLETS.