Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations

Spectrochim Acta A Mol Biomol Spectrosc. 2007 Oct;68(2):250-6. doi: 10.1016/j.saa.2006.11.023. Epub 2006 Nov 24.

Abstract

New, simple, cost effective, accurate and reproducible UV-spectrophotometric methods were developed and validated for the estimation of moxifloxacin in bulk and pharmaceutical formulations. Moxifloxacin was estimated at 296 nm in 0.1N hydrochloric acid (pH 1.2) and at 289 nm in phosphate buffer (pH 7.4). Beer's law was obeyed in the concentration range of 1-12 microg ml(-1) (r2=0.9999) in hydrochloric acid and 1-14 microg ml(-1) (r2=0.9998) in the phosphate buffer medium. The apparent molar absorptivity and Sandell's sensitivity coefficient were found to be 4.63 x 10(4) l mol(-1) cm(-1) and 9.5 ng cm(-2)/0.001 A in hydrochloric acid; and 4.08 x 10(4) l mol(-1) cm(-1) and 10.8 ng cm(-2)/0.001 A in phosphate buffer media, respectively indicating the high sensitivity of the proposed methods. These methods were tested and validated for various parameters according to ICH guidelines. The detection and quantitation limits were found to be 0.0402, 0.1217 microg ml(-1) in hydrochloric acid and 0.0384, 0.1163 microg ml(-1) in phosphate buffer medium, respectively. The proposed methods were successfully applied for the determination of moxifloxacin in pharmaceutical formulations (tablets, i.v. infusions, eye drops and polymeric nanoparticles). The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming and hence can be suitably applied for the estimation of moxifloxacin in different dosage forms and dissolution studies.

Publication types

  • Validation Study

MeSH terms

  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / analysis
  • Anti-Bacterial Agents / chemistry
  • Aza Compounds / administration & dosage
  • Aza Compounds / analysis*
  • Aza Compounds / chemistry
  • Dosage Forms
  • Drug Compounding
  • Fluoroquinolones
  • Hydrogen-Ion Concentration
  • Moxifloxacin
  • Quinolines / administration & dosage
  • Quinolines / analysis*
  • Quinolines / chemistry
  • Sensitivity and Specificity
  • Spectrophotometry, Ultraviolet / methods*
  • Spectrophotometry, Ultraviolet / statistics & numerical data

Substances

  • Anti-Bacterial Agents
  • Aza Compounds
  • Dosage Forms
  • Fluoroquinolones
  • Quinolines
  • Moxifloxacin