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ABSTRACT
A simple and sensitive high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of the levofloxacin and ornidazole in combined dosage forms. The stationary phase used was precoated silica gel 60F^sub 254^ plate. The mobile phase used was a mixture of n-butanol: ethanol: ammonia (8 M) (5:0.5:1.5, v/v/v). The detection of spots was carried out densitometrically using a UV detector at 310 nm in absorbance mode. This system was found to give compact spots for levofloxacin (R^sub f^ value of 0.31 ± 0.003) and ornidazole (R^sub f^ value of 0.83 ± 0.008). The method was validated in terms of linearity, accuracy, precision, limit of detection, limit of quantification and specificity. The calibration curve was found to be linear between 40 to 140 and 80 to 280 ng/spot for levofloxacin and ornidazole, respectively with significantly high value of correlation coefficient (r^sup 2^ > 0.99). The limits of detection and quantitation were found to be 9.98 and 30.25 ng/spot, respectively for levofloxacin and 21.12 and 64.01 ng/spot, respectively for ornidazole. The proposed method was found to be accurate, precise, reproducible and specific and can be applicable for the simultaneous determination of levofloxacin and ornidazole in tablet dosage form.
Keywords: Levofloxacin, Ornidazole, High performance thin layer chromatography, Validation, Specificity, Accuracy.
(ProQuest: ... denotes formulae omitted.)
INTRODUCTION
Levofloxacin (LFX) is chemically, (")-(S)-9-Fluoro- 2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7- oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug substance ofloxacin1. LFX is mainly used in the treatment of bacterial infections caused by grampositive microorganisms2. Ornidazole (ORN) is chemically, a-(chloromethyl)-2-methyl-5-nitroimidazole-1- ethanol, is a 5-nitroimidazole derivative, used as an antiinfective agent3. ORN is used in the treatment of susceptible protozoal infections and also in the treatment and prophylaxis of anaerobic bacterial infections4. LFX is official in IP. IP5 describes non-aqueous titration method for its estimation. Literature survey reveals high performance liquid chromatography (HPLC)6-12 and spectrophotometry13 methods for estimation of LFX in biological fluids as well as in pharmaceutical dosage forms. Ornidazole is official in IP. The IP14 describes non-aqueous titration method for estimation of ORN. Literature survey reveals HPLC15-16, flow-injection analysis17, voltammetry18 and spectrophotometry19-20 methods for the determination of ORN in pharmaceutical formulations as well as...