Determination of gatifloxacin in bulk and tablet preparations by high-performance liquid chromatography

J AOAC Int. 2006 May-Jun;89(3):642-5.

Abstract

A sensitive, precise, and specific high-performance liquid chromatographic (HPLC) method was developed for the assay of gatifloxacin (GATX) in raw material and tablets. The method validation parameters yielded good results and included the range, linearity, precision, accuracy, specificity, and recovery. It was also found that the excipients in the commercial tablet preparation did not interfere with the assay. The HPLC separation was carried out by reversed-phase chromatography on a C18 absorbosphere column (250 x 4.6 mm id, 5 microm particle size) with a mobile phase composed of acetic acid 5%-acetonitrile-methanol (70 + 15 + 15, v/v/v) pumped isocratically at a flow rate of 1.0 mL/min. The effluent was monitored at 287 nm. The calibration graph for GATX was linear from 4.0 to 14.0 microg/mL. The interday and intraday precisions (relative standard deviation) were less than 1.05%.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetic Acid / chemistry
  • Acetonitriles / chemistry
  • Chemistry Techniques, Analytical / methods*
  • Chemistry, Pharmaceutical / methods*
  • Chromatography, High Pressure Liquid / methods*
  • Dosage Forms
  • Fluoroquinolones / analysis*
  • Fluoroquinolones / isolation & purification
  • Gatifloxacin
  • Methanol / chemistry
  • Models, Chemical
  • Pharmaceutical Preparations
  • Reproducibility of Results
  • Tablets
  • Time Factors

Substances

  • Acetonitriles
  • Dosage Forms
  • Fluoroquinolones
  • Pharmaceutical Preparations
  • Tablets
  • Gatifloxacin
  • Acetic Acid
  • Methanol
  • acetonitrile