Ej. Park et al., HPLC ASSAY AND BIOEQUIVALENCE EVALUATION OF BIPHENYL DIMETHYL DICARBOXYLATE (DDB) PRODUCTS, Journal of liquid chromatography & related technologies, 21(12), 1998, pp. 1833-1843
Citations number
14
Categorie Soggetti
Chemistry Analytical","Biochemical Research Methods
A high-performance liquid chromatographic (HPLC) method was developed
for biphenyl dimethyl dicarboxylate (DDB) detection in human serum and
bioequivalence (BE) of two commercial DDB tablets was evaluated in 14
normal male subjects. The most suitable extracting solvent for DDB in
serum was evaluated among dichloromethane, ether, ethylacetate, hexan
e, and pentane. Pentane:ether (9:1) mixture showed good extraction rec
overy of DDB from serum and also excluded serum components, which inte
rfere the peak of DDB when assayed. HPLC conditions were as follows: U
V absorbance detector, 280 nn; column, mu-Bondapak C-18; mobile phase,
10 mM phosphate buffer (pH 6.0), 33% acetonitrile, and 17% methanol;
sensitivity, 0.005 aufs. BE was evaluated by 2x2 Latin square crossove
r method. DDB tablets (200 mg as DDB) were given orally and the serum
concentration was detected by HPLC. The pharmacokinetic parameters, AU
C(t), C-max, and t(max) obtained after dosing were statistically analy
zed by ANOVA for crossover design, The results for all parameters were
within 20% difference of mean value between reference and test drug.
The results of ANOVA showed no significant differences for between gro
up or subject and period. From the results, it is concluded that the b
ioavailability of test drug is not significantly different from refere
nce drug and the two drugs are bioequivalent.