Validation of a simple and rapid HPLC method for determination of metronidazole in dermatological formulations

Drug Dev Ind Pharm. 2008 Aug;34(8):840-4. doi: 10.1080/03639040801928598.

Abstract

A rapid and simple method using an isocratic high-pressure liquid chromatography (HPLC) and UV detection for the determination of metronidazole in dermatological formulations is presented. Metronidazole samples were extracted with a solution composed of 60% methanol and 40% mobile phase by a procedure that can be completed in less than 10 min. Subsequent separation and quantification was accomplished in less than 20 min using reversed-phase HPLC with isocratic elution with 0.01% trifluoroacetic acid/acetonitrile (85:15%, vol/vol). Validation experiments confirmed the precision and accuracy of the method. When applied to a commercial metronidazole cream and gel formulation, recoveries of 100.4% for cream formulations and 102.3% for gel formulations were obtained. The method should facilitate studies of the formulation compatibility of metronidazole topical formulations with agents that may improve its clinical tolerability for treatment of rosacea.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Anti-Infective Agents / analysis*
  • Chromatography, High Pressure Liquid
  • Dermatologic Agents / analysis*
  • Linear Models
  • Metronidazole / analysis*

Substances

  • Anti-Infective Agents
  • Dermatologic Agents
  • Metronidazole