HPLC ASSAY OF MODEL TABLET FORMULATIONS CONTAINING METRONIDAZOLE AND CIPROFLOXACIN
Keywords:
Metronidazole, Ciprofloxacin, RP-HPLC, validation, model tablet formulations, quality controlAbstract
Objective: This paper describes development and validation of a high-performance liquid chromatographic analytical procedure for simultaneously determination of metronidazole and ciprofloxacin in a model tablet formulations.
Methods: The separation was achieved with a LiChrosorb® RP-18 (250 x 4.6 mm) column, at 33 °C temperature with isocratic mode and a mobile phase containing triethylamine: o-phosphoric acid and аcetonitrile (0.02:80:20 v/v/v). The flow rate was 1.0 ml/min and the eluent was monitored at 290 nm.
Results: The selected chromatographic conditions were found to separate effectively metronidazole and ciprofloxacin with a retention time of 3.46 min and 6.68 min, respectively. The method was validated for analytical parameters specificity, linearity, precision, accuracy, LOD and LOQ. The calibration curves were linear in the concentration range of 12.5-100.0 µg/ml for metronidazole and ciprofloxacin. The recovery for metronidazole and ciprofloxacin was 100.1 % and 100.2 %, respectively.
Conclusion: The analytical procedure was applied to quality control of model tablet formulations. It was established that the developed analytical procedure was successfully used for routine analysis of metronidazole and ciprofloxacin in model tablet dosage forms without any interference from included excipients.
Keywords: Metronidazole, Ciprofloxacin, RP-HPLC, Validation, Model tablet formulations, Quality control
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