High-performance liquid chromatographic determination of clindamycin in human plasma or serum: application to the bioequivalency study of clindamycin phosphate injections.
This paper presents an assay of clindamycin phosphate injection in human plasma or serum. A 0.5-ml volume of plasma was used with the internal standard, propranolol. The sample was loaded onto a silica extraction column. The column was washed with deionized water and then eluted with methanol. The eluates were evaporated under nitrogen gas. The residue was reconstituted with the mobile phase and injected onto the high-performance liquid chromatographic system: a 5-micron, 25 cm X 4.6 mm I.D. ODS2 column was used with acetonitrile, tetrahydrofuran and 0.05 M phosphate buffer as the mobile phase and with ultraviolet detection at 204 nm. A limit of quantitation of 0.05 microgram/ml was found, with a coefficient of variation of 11.6% (n = 6). The linear range is between 0.05 and 20.00 micrograms/ml and gives a coefficient of determination (r2) or 0.9992. The method has been successfully applied to the bioavailability study of two commercial preparations of clindamycin phosphate injection (300 mg each) in twelve healthy adult male volunteers.
Liu
C M
CM
Department of Pharmaceutical Technology, Mithra Bioindustry Co., Ltd., Taipei, Taiwan.
Chen
Y K
YK
Yang
T H
TH
Hsieh
S Y
SY
Hung
M H
MH
Lin
E T
ET
D000328:Adult; D000900:Anti-Bacterial Agents / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002981:Clindamycin / Q000031:analogs & derivatives* / Q000097:blood*; D006801:Humans; D008297:Male; D012015:Reference Standards; D012016:Reference Values; D013056:Spectrophotometry, Ultraviolet
D000900:Anti-Bacterial Agents; D002981:Clindamycin; C007084:clindamycin phosphate