Optimization and validation of a CZE method for Rufloxacin hydrochloride (cas 106017-08-7) determination in coated tablets

Add time:07/20/2019    Source:sciencedirect.com

A simple and rapid capillary electrophoresis method with UV detection was developed and validated for the determination of Rufloxacin hydrochloride (cas 106017-08-7) in coated tablets. An experimental design strategy (Doehlert design and desirability function) allowed the analytical parameters to be simultaneously optimized in order to determine rufloxacin hydrochloride with high peak area/migration time ratio, good efficiency and short analysis time. Optimized analyses were run using boric acid 0.10 M adjusted to pH 8.8 as BGE and setting voltage and temperature at 18 kV and 27 °C, respectively. Pefloxacin mesylate was used as internal standard and run time was about three minutes. The method was validated for the drug substance and the drug product according to the ICH3 guidelines. Robustness was tested by experimental design using an eight-run Plackett–Burman matrix.

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