Reverse phase high performance liquid chromatography method Development and Validation for Simultaneous Determination of Hydroxychloroquine Sulphate and Nitazoxanide Bulk Drug and Their Formulation
Abstract
The present study aimed to develop and validate the simultaneous determination of hydroxychroquine sulphate and nitazoxanide in bulk and their formulation. Under isocratic conditions, the samples were analysed by the HPLC equipment using a HiQ SiL C18 (250mm, × 4.6mm, D., 5µm). The mobile phase was composed of methanol, acetonitrile, and water (30:40:30) at an average flow rate of 0.8 ml/min. Orthophosphoric acid was used to bring the pH of the water up to 3. For both medications, the validation findings of this approach indicate a correlation value of 0.999. With orthophosphoric acid serving as a mobile phase and an isoabsorptive point wavelength of 340 nm, the HPLC technique was designed for methanol: acetonitrile: water (30:40:30) (pH of water adjusted up to 3). For hydroxychroquine sulphate, the linearity range was 4–20 µg/ml , while for nitazoxanide, it was 10–50 µg/ml . The devised technique was accurate, with an intra-day accuracy of 0.5% and an inter-day precision of 1.7%, with a percentage RSD value not exceeding 2. The percentage degradation of hydroxychloroquine sulphate and nitazoxanide by acidic, basic, oxidative, thermal, and photolytic processes. The findings were statistically evaluated in accordance with the principles outlined in ICH Q2 (R1).
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