| Summary: | Ciprofloxacin is a fluoroquinolone type antibiotic agent that is being widely
used for the treatment of several bacterial infections. It exhibits broad spectrum
antimicrobial activity against Gram negative and Gram positive bacteria. This
study aims to develop and validate an HPLC method couple with a UV detection
for determination of ciprofloxacin in spiked human plasma and its application for
bioequivalence study.
HPLC method using an RP-C18 column (Lachrom Hitachi, 250 x 4,6 mm.,
5μm), mobile phase of phosphate buffer (pH 3 ± 0,1 ) : acetonitrile (87 : 13) , a
flow rate of 1,5 mL / min with ultraviolet detection at 276,6 nm. The limid of
detection is 0,07 μg/mL. The regression equation are linear (r > 0,999)
This method was successfully applied to bioequivalence study of two
product of 500 mg ciprofloxacin. For bioequivalence study was obtained (90%
CI) ratio of Cmax = 74,08-124,60%, (90% CI) AUCt(0-12) ratio = 83,53-122,14 %
and (90% CI) ratio AUCt(0-
) = 86,07- 120,92%.
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