A New RP-UPLC Method Development and Validation for the Bulk Drugs Nitazoxanide and Ofloxacin

Author(s): P. Rama Bharathi*, S. Marakatham, R.V. Valli kumara and Meruva Sathish Kumar

Abstract: A new precise, accurate, rapid method has been developed for the simultaneous estimation of Ofloxacin and Nitazoxanide in pharmaceutical dosage form by RP-UHPLC the optimum wavelength for the determination of Ofloxacin and Nitazoxanide was selected at 230 nm on the basis of isobestic point. Various trials were performed with different mobile phases in different ratios, but finally Sodium Phosphate Buffer pH 3.0: Acetonitrile (80:20%v/v) was selected as good peak symmetry and resolution between the peaks was observed. The Retention time of Ofloxacin and Nitazoxanide were found to be 1.527 and 2.890 min respectively. The Retention times for both the drugs were considerably less compared to the Retention time obtained for the drugs in the other mobile phase. The different analytical performance parameters such as linearity, precision, accuracy and specificity were determined according to International Conference on Harmonization ICH Q2B guidelines. The calibration curve was obtained by plotting peak area versus the concentration over the range of 100-300 μg/ml for Nitazoxanide and250-750 μg/ml for Ofloxacin. From linearity the correlation coefficient R2 value was found to be 0.999 for Nitazoxanide and 0.999 for Ofloxacin. The proposed HPLC method was also validated for system suitability, system precision and method precision. The %RSD in the peak area of drug was found to be less than 2%. The number of theoretical plates was found to be more than 2000, which indicates efficient performance of the column. The percentage of recovery of Ofloxacin and Nitazoxanide were found to be 99.5 and 99.2 % respectively, shows that the proposed method is highly accurate.

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