DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF SITAFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Keywords:
Sitafloxacin (SFX), RP-HPLC, ValidationAbstract
Objective: A simple, specific, and precise reversed phase high performance liquid chromatography method was developed and validated as per the ICH guidelines for the determination of Sitafloxacin in bulk and tablet dosage forms.
Methods: The quantitation was carried out by using Symmetry C18 ((5 µm, 100X4.6 mm) column at 300c with Water: Acetonitrile in ratio of 70:30 % V/V as mobile phase. The flow rate is 0.9 mL/min and the estimation was carried out by using PDA detector at 300 nm.
Results: The retention time of Sitafloxacin was 2.198 minutes. The linearity was observed from 5-25 μg/mL with correlation coefficient 0.9999. The LOD and LOQ were found to be 0.429μg/mL and 1.415μg/mL respectively.
Conclusion: The Statistics data for the Sitafloxacin was concluded that the method was found to be simple, reliable, selective, reproducible and accurate. The method was successfully used for quality control analysis of Sitafloxacin in bulk and Pharmaceutical dosage forms.
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