Simultaneous High-Performance Liquid Chromatographic Determination of Nitazoxanide and Ofloxacin in Tablet Formulation

Vipul P. Rane, Devanand. B. Shinde

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Nitazoxanide, Ofloxacin, RP-HPLC, Tablet formulation, Method validation


A simple, rapid, and precise method was developed for the quantitative simultaneous determination of nitazoxanide and ofloxacin in new tablet formulation. Chromatographic separation of the two drugs was achieved on an Ymc pack-AM C18, 25-cm analytical column using mobile phase consisting of 10 mmol L-1 dipotassium hydrogen phosphate:acetonitrile (65:35, v/v) finally the pH of the mobile phase was adjusted to 7.0 using o- phosphoric acid. The instrumental settings are flow rate of 1 mL min-1, column temperature at 30oC, and detector wavelength of 254 nm. The internal standard method was used for the quantification. Caffeine was used as an internal standard. The method validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness. The calibration curve shows excellent linearity over the concentration ranges of ofloxacin and nitazoxanide 20-200 μg mL-1 and 8-80 μg mL-1, respectively. The separation was completed less than 6 minutes. The proposed method can be used for the quality control of formulation products.