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

• Published in: Journal of AOAC International Vol. 88; no. 6; p. 1649
• Main Authors: Ferreyra, Carola F, Ortiz, Cristina S
• Format: Journal Article
• Language: English
• Published: England 01.11.2005
• Subjects: 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
• ISSN: 1060-3271
• DOI: 10.1093/jaoac/88.6.1649

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.