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THE PHARMA REVIEW (JULY 2009)

Spectrophotometric Methods for determination oF Ornidazole and Gatifloxacin in Tablet Dosage Form

Hemlata T. Pakhale, S. P. Wate, Nilima M. Nimje, R. J. Oswal

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 g/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 g/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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