Novel Separation and Quantitative Determination of Levofloxacin, Prulifloxacin, Gatifloxacin, Sparfloxacin, Moxifloxacin and Balofloxacin Fluoroquinolone Antibacterials in Pharmaceutical Dosage Forms by RP-HPLC Method
For the first time, Simple, selective, sensitive RP-HPLC method developed for the separation and quantitative estimation of Levofloxacin (LEVO), Prulifloxacin (PRFX), Gatifloxacin (GATI), Sparfloxacin (SPAR), Moxifloxacin (MOXI) and Balofloxacin (BALO) relating to fluoroquinolone antibacterials in pharmaceutical dosage forms. The important advantage of the developed method was that the six separate drugs could be estimated on a single chromatographic system without modifications in detection wavelength and mobile phase by RP-HPLC. The chromatographic separation of the selected drugs carried out on Welchrom C18 column consisting of 250 mm X4.6 mm, 5 µm particle size utilizing mixture of 10 mM phosphate buffer (pH 3.1): Acetonitrile in the ratio of 70:30,v/v as mobile phase at the flow rate of 1 mL/min with detection wavelength at 293 nm by using UV spectrophotometric detector with total run time of 10 minutes and 3.613, 4.230, 4.707, 5.497, 5.880 and 6.253 minutes of retention time, 12,261, 12,554, 13,157, 14,761, 14,912 and 15,916 of plate number, 1.106, 1.067, 1.040 and 1.073, 1.030 and 1.086 tailing factors were obtained for LEVO, PRFX, GATI, SPAR, MOXI and BALO respectively. All calibration curves for six drugs showed indicated linearity over a concentration range of 2-10 µg/mL. The results regarding to limit of detection (LOD) and limit of quantitation (LOQ) for LEVO, PRFX, GATI, SPAR, MOXI and BALO were found to be 0.116 µg/mL and 0.348 µg/mL; 0.152 µg/mL and 0.460 µg/mL; 0.084 µg/mL and 0.255 µg/mL; 0.186 µg/mL and 0.558 µg/mL, 0.162 and 0.493, 0.112 and 0.390 respectively. These results clearly show the low values of LOD and LOQ. The said proposed method utilized for quantification of the marketed formulation. The mean assay values for LEVO, PRFX, GATI, SPAR, MOXI and BALO arrived at 99.317±0.990%, 99.9±0.04%, 99.9±0.02%, 99.45±0.01%, 99.945±0.056% and 99.68±0.09% respectively.
Prof. Panchumarthy Ravisankar
Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, Guntur District – 522 213, Andhra Pradesh, India
Dr. Ch. V. Prasada Rao
Department of Pharmaceutics, Vignan Pharmacy College, Vadlamudi, Guntur District – 522 213, Andhra Pradesh, India.
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