A stability indicating RP-HPLC method was developed and validated
for the determination of Gemifloxacin in tablet formulation. The
drug was subjected to forced degradation study in terms of acidic,
thermal, oxidative, photo and basic stresses. Degradation products
produced as a result of stress testing were successfully separated
through C18 column (250 x 4.6 mm, 5 m) using ammonium acetate
buffer (pH 2.7; 0.05 M) and acetonitrile (70:30, v/v) as a mobile
phase at a flow rate of 0.7 mL/min. The diode array detection was
performed at 272 nm. The method was linear over the concentration
range of 0.256-128 g/mL with correlation coefficient equal to
0.9990. The LOD and LOQ were 10 ng/mL and 30 ng/mL respectively.
The proposed method was validated according to ICH guidelines. The
method showed adequate separation of Gemifloxacin from its stress
induced degradation products and excipients with resolution greater
than 1.5 within 11 minutes. The method is therefore considered as
stability indicating, rapid and suitable for the chromatographic
purity and assay determination of Gemifloxacin not only in routine
quality control analysis but also for stability studies.
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