Simultaneous determination of bifonazole and tinctures of calendula flower in pharmaceutical creams by reversed-phase liquid chromatography

J AOAC Int. 2005 Nov-Dec;88(6):1649-54.

Abstract

The aim of this research was to develop and validate a sensitive, rapid, easy, and precise reversed-phase liquid chromatography (LC) method for stability studies of bifonazole (I) formulated with tinctures of calendula flower (II). The method was especially developed for the analysis and quantitative determination of I and II in pure and combined forms in cream pharmaceutical formulations without using gradient elution and at room temperature. The influence on the stability of compound I of temperature, artificial radiation, and drug II used for the new pharmaceutical design was evaluated. The LC separation was carried out using a Supelcosil LC-18 column (25 cm x 4.6 mm id, 5 microm particle size); the mobile phase was composed of methanol-0.1 M ammonium acetate buffer (85 + 15, v/v) pumped isocratically at a flow rate of 1 mL/min; and ultraviolet detection was at 254 nm. The analysis time was less than 10 min. Calibration graphs were found to be linear in the 0.125-0.375 mg/mL (rI = 0.9991) and 0.639-1.916 mg/mL (rII = 0.9995) ranges for I and II, respectively. The linearity, precision, recovery, and limits of detection and quantification were satisfactory for I and II. The results obtained suggested that the developed LC method is selective and specific for the analysis of I and II in pharmaceutical products, and that it can be applied to stability studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / chemistry
  • Antifungal Agents / analysis
  • Buffers
  • Calendula / metabolism*
  • Calibration
  • Chemistry Techniques, Analytical / methods*
  • Chromatography, Liquid / methods*
  • Dosage Forms
  • Hot Temperature
  • Imidazoles / analysis*
  • Magnetic Resonance Spectroscopy
  • Methanol / chemistry
  • Pharmaceutical Preparations / analysis*
  • Photochemistry
  • Plant Extracts / analysis*
  • Reproducibility of Results
  • Spectrophotometry
  • Temperature
  • Time Factors

Substances

  • Acetates
  • Antifungal Agents
  • Buffers
  • Dosage Forms
  • Imidazoles
  • Pharmaceutical Preparations
  • Plant Extracts
  • bifonazole
  • ammonium acetate
  • Methanol