Abstract

BackgroundClotrimazole is used to treat topical vaginal yeast infections. Vaginal gelatin film formulations of clotrimazole were prepared, and the present study aims to develop an HPLC method for quantifying clotrimazole in the film formulation.ResultsThe chromatographic separation of components was achieved on a Phenomenex Luna C18(2) (150 × 4.6 mm, 5 μm) stationary phase with Phenomenex Security Guard Cartridge C18 (4 × 3 mm) using acetonitrile and water (70:30% v/v) as mobile phase. The flow rate was 1.0 ml/min and the absorbance was monitored at 210 nm. Clotrimazole was eluted at 5.6 min. The procedures and capabilities of the method were evaluated against the criteria for system suitability, specificity, linearity, precision, accuracy, and robustness as defined by the ICH guidelines. The method showed good linearity (R2 = 0.999) in the range of 10–50 μg/ml and an average recovery of 101.05%.ConclusionThe method could be applied for the quantification of clotrimazole in the gelatin film formulation.

Highlights

  • Clotrimazole is used to treat topical vaginal yeast infections

  • Clotrimazole, an imidazole derivative (Fig. 1), is a broadspectrum antifungal. It inhibits the biosynthesis of ergosterol, a component of the fungal cell membrane, and this affects the permeability of the cell membrane, which results in leakage and loss of essential intracellular compounds and causes cell lysis [1]

  • Chromatographic conditions The chromatographic separation of components was achieved on a Phenomenex Luna C18(2) (150 × 4.6 mm, 5 μm) stationary phase with Phenomenex Security Guard Cartridge C18 (4 × 3 mm) using acetonitrile and water (70:30% v/v) as mobile phase

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Summary

Introduction

Clotrimazole is used to treat topical vaginal yeast infections. Clotrimazole, an imidazole derivative (Fig. 1), is a broadspectrum antifungal. It inhibits the biosynthesis of ergosterol, a component of the fungal cell membrane, and this affects the permeability of the cell membrane, which results in leakage and loss of essential intracellular compounds and causes cell lysis [1]. Clotrimazole is used to treat vaginal and skin yeast or fungal infections, rashes, oral thrush, athlete’s foot, jock itch, ringworm, etc. This is administered orally or applied topically. Clotrimazole gelatin films have been developed for vaginal application in our laboratory

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