Abstract

Background: Econazole nitrate and triamcinolone acetonide are one of the topical antifungal corticosteroid fixed combinations. Although this combination has been literately investigated, yet their ternary mixture with benzoic acid as preservative lack of a simple method for its determination.

Objective: The objective of this work is to present simple, accurate, precise and low cost reversed-phase liquid chromatography (RP-LC) method for the separation and determination of econazole nitrate, triamcinolone acetonide and benzoic acid in a ternary mixture.

Methods: Separation was conducted on Mediterranea C18 (150mm x 4.6mm, 5μm) column using methanol: 50 mM potassium dihydrogen phosphate buffer (pH 2.60±1), (70:30, v/v) as a mobile phase at ambient temperature. Isocratic flow rate at 1 ml/min was used and UV detection was carried out at 230 nm. The Linearity, accuracy and precision of the developed method investigated as per ICH guidelines.

Results: Good separation of two drugs, benzoic acid as preservative and excipients of dosage form was achieved with acceptable retention times (< 8 min). Validation parameters tested including linearity, accuracy and precision were found to be satisfactory over the concentration range (10-200 µg/ml) for econazole nitrate, (1-20 µg/ml) for triamcinolone acetonide and (2-40 μg/ml) for benzoic acid.

Conclusion: The proposed method showed good separation and demonstrated adequate specificity, robustness and accuracy for the quantification of the tested drugs in laboratory prepared mixtures and in pharmaceutical preparations.

Keywords: Econazole nitrate, triamcinolone acetonide, banzoic acid, reversed-phase liquid chromatography, pharmaceutical preparation, ternary mixture.

Graphical Abstract