Development and validation of an HPLC-uv method for the determination of gatifloxacin in bulk material, pharmaceutical formulations, human plasma and metal complexes. - Excipients

Development and validation of an HPLC-uv method for the determination of gatifloxacin in bulk material, pharmaceutical formulations, human plasma and metal complexes.
2006 Oct
Sultana N, Arayne MS, Naz A.
Pak J Pharm Sci.
PubMed
Research Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi.
A simple reversed phase HPLC method was developed for the quantitative determination of gatifloxacin (GTX) in the bulk material, pharmaceutical formulations and human serum using Mediterranea C18 (25 x 0.46mm, 5mm) column. The mobile phase, acetonitrile, methanol and water (40:40:20 v/v pH 2.7 adjusted by phosphoric acid), was delivered at a flow rate of 1.0 ml/min. The eluent was monitored using spectrophotometric detection at 286 nm. The method is specific to GTX and able to resolve the drug peak from formulation excipients and metal impurities. The method is accurate (99.18-101.87%), precise (intra-day variation 0.14-1.67% and inter-day variation 0.32-1.80%) and linear within the range 0.1-25mug/ml (R2=0.999) concentration and was successfully used in monitoring left over drug in drug-metal complexes. The detection limit of GTX at a signal-to-noise ratio of 3 was 1.73 ng/ml in human plasma while quantification limit in human serum was 5.77 ng/ml. The proposed method is applicable to routine analysis of GTX in pharmaceutical formulations as well as in human plasma samples.
PMID: 17105703 [PubMed - in process]