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Abstract: Two simple, precise and accurate
methods for simultaneous estimation of ornidazole and
gatifloxacin in combined dosage form have been
described. Method 1 involves formation of Q-absorbance
equation at 278.0 nm and 285.0 nm (isoabsorptive point),
while method 2 involves formation of simultaneous
equation at 278.0 nm and 292.5 nm, using 0.1 M HCl as
solvent. Both the methods were validated, and the
results were compared statistically. They were found to
be precise, accurate, and specific. The proposed methods
were successfully applied to estimation of ornidazole
and gatifloxacin in combined tablet formulation.
Introduction
Gatifloxacin (GAT),
1-Cyclochlopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic
acid is a new fluroquinolone with potent and broad
spectrum activity against microorganism. Ornidazole (ORN),
1-(3-Chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole
is an antimicrobial agent used in treatment of
susceptible protozoal infections and anaerobic bacterial
infection. Extensive literature survey revealed
spectrophotometric determination of GAT in tablet dosage
form, RP-HPLC and HPTLC has been reported in tablet
dosage forms. Number of methods have been reported for
estimation of GAT and ORN individually or in combination
with other drugs. No reports were found for simultaneous
spectrophotometric determination of GAT and ORN in
combined tablet dosage form. Aim of the present work was
to developed simple, economical, rapid, accurate and
precise spectrophotometric methods for determination of
GAT in combination with ORN in pharmaceutical
formulation. The proposed methods were validated as per
the International Conference on Hormonization (ICH)
guidelines.
Materials and Methods
Instrumentation
The instrument used in the present study was SHIMADZU
double beam UV Visible spectrophotometer (Model 1601).
The slit width was 2 nm and wavelength scanning speed
being 400 nm/min. The absorption spectra of the test and
reference solutions were recorded in 1 cm matched quartz
cells over the range 200-400 nm. All weighing were done
on electronic balance (Model Shimadzu AY-120).
Preparation of standard stock solutions
GAT standard stock solution (100 µg/ml) was prepared by
weighing a 25 mg portion of GAT (Dr. Reddy Laboratories
Ltd., Hyderabad) standard, it was transferred to a 25 ml
volumetric flask, and volume made to 25 ml with 0.1 M
HCl. ORN standard stock solution (100 µg/ml) was
prepared by weighing a 25 mg portion of ORN (Universal
Medicaments Pvt. Ltd., Nagpur) standard, it was
transferred to a 25 ml volumetric flask, and volume made
to 25 ml with 0.1 M HCl.
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