A simple, precise, accurate RP-HPLC method was developed for
the estimation of Garenoxacin mesylate in human plasma using Ciprofloxacin
Hydrochloride as an internal standard. The chromatographic conditions optimized
were Zorbax Eclipse XDB C18 (250 x 4.6 mm, 5µ) column, Mobile phase 0.1%
OrthoPhosphoric Acid and Acetonitrile in the ratio of 50:50 (% v/v) with a flow
rate of 1.0 ml/min and injection volume of 50 µL. The detection wavelength was
set to 240 nm with a column temperature of 30°C. The retention time of
Garenoxacin mesylate was found to be 4.0 min. % Coefficient of Variation of
Garenoxacin mesylate was found to be 4.30. % Recovery was obtained as 98.97%.
The linearity of the proposed method was established in the concentration range
of 0.04 to 4 µg/ml (Correlation Coefficient = 0.999). The lower limit of
quantification was 0.04 µg/ml which reached the level of a drug possibly found
in human plasma. Further, the reported method was validated as per the ICH
guidelines and found to be well within the acceptable range. The method was
successfully applied to a pharmacokinetic study after oral administration of
immediate-release Zinox tablets (200 mg) in healthy Albino rabbits. The mean
Cmax was found to be 5540 ng/ml, which occurred at a Tmax of 1.00 hr. The
half-life and AUC0-α values were found to be 13.52 hr and 72187 ng. hr/ml. The
method was found to be applicable to bioequivalence studies.
Author(s) Details:
A. Ajitha,
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Sri
Ramachandra Institute of Higher Education and Research (Deemed to be
University), No.1 Ramachandra Nagar, Porur, Chennai - 600 116, India.
K. Sujatha,
Department
of Pharmaceutical Chemistry, Faculty of Pharmacy, Sri Ramachandra Institute of
Higher Education and Research (Deemed to be University), No.1 Ramachandra
Nagar, Porur, Chennai - 600 116, India.
Please see the link here: https://stm.bookpi.org/ACPR-V7/article/view/13733
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