Purpose:
The present study was
undertaken to develop a validated, rapid, simple and
low-cost ultraviolet (UV) spectrophotometric method for
estimating levofloxacin (LFX) in dosage preparations.
Method:
UV
spectrophotometric analysis was performed
spectrophotometrically at a pre-determined λmax of 290
nm with 0.1M HCl as diluent/blank. The method was
validated for linearity, accuracy, precision,
reproducibility, and specificity as per International
Conference on Harmonization (ICH) guidelines. The method
was also used in the determination of the content of
levofloxacin in two commercial brands of levofloxacin in
the Nigerian market.
Results:
The regression data for the calibration plots exhibited
good linear relationship (r = 0.999) over a
concentration range of 0.25 – 12.0 µg/ml and the linear
regression equation was y = 0.075x + 0.018. Mean
recovery accuracy was 98.7 %, which was not
significantly different from the expected value (p =
0.05), while coefficient of variation (CV) for both
intra-day and inter-day was < 7 %. The method was
specific for levofloxacin in the presence of common
excipients, and when it was applied to two marketed
brands, levofloxacin content was 99.69 ± 2.38 and 102.65
± 3.64 %, respectively, of labeled claim.
Conclusion:
The proposed method gave
good validation results and the statistical analysis
performed proved that the method is precise, accurate
and reproducible, and hence can be employed for routine
analysis of LFX in bulk and commercial formulations.
Keywords:
Levofloxacin, Spectrophotometric method, Validation,
Dosage formulations, Quality control
