DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF NITAZOXANIDE AND OFLOXACIN IN COMBINED PHARMACEUTICAL DOSAGE FORMS

A simple, rapid, specific and reproducible reverse phase HPLC method was developed and validated for the simultaneous separation and estimation of the Nitazoxanide and Ofloxacin from the commercially available tablet dosage form. The chromatography was carried out using a combination of 0.863% (w/v) ammonium dihydrogen orthophosphate buffer and Acetonitrile (45:55 ratio (v/v)) at a flow rate of 1.0 ml/min and was monitored at 240 nm wavelength. The method was statistically validated by the study of linearity, accuracy, precision, limit of detection, limit of quantification, recovery and robustness. The retention time of Ofloxacin and Nitazoxanide were 2.099 + 0.010 and 5.623 + 0.03 minutes respectively. The calibration curve showed the excellent linearity over a concentration range of 3.125 μg to 0.5 mg/ml for Nitazoxanide and 1.25 μg to 0.2 mg/ml for Ofloxacin with correlation coefficients of 0.99999 and 0.99998 respectively. The proposed method can be used for the simultaneous estimation of Ofloxacin and Nitazoxanide in the combined dosages forms.

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