Abstract

Development and Validation of HPTLC method for Determination of Voriconazole in Human Plasma

Author(s): Mohit G. Dewani, Tejas C. Borole, Sejal P. Gandhi, A. R. Madgulkar, Mrinalini C. Damle

Voriconazole is a new antifungal agent that is a derivative of fluconazole, having wide-spectrum activity and a fungicidal action against Candida and Aspergillus species. Voriconazole displays non-linear pharmacokinetics in adults but has linear pharmacokinetics in children. Interindividual variability is generally high; both in children and adults, and diverse manifestations of toxicity are possibly attributed to high drug concentrations. This indicates the need to monitor voriconazole concentration in plasma after oral dose. A simple, selective and sensitive high performance thin layer chromatographic method for the determination of voriconazole in human plasma is developed and validated. After precipitation of plasma proteins with acetonitrile, the protein-free supernatant was spotted on plates precoated with silica gel 60 F254. Cephalexin was used as an internal standard. The mobile phase consisted of a mixture of toluene : methanol : triethylamine in the ratio of 6:4:0.1 v/v/v. The drug showed considerable absorbance at 254 nm. The method was found to be linear over the concentration range of 50– 400 ng/band. Mean drug recovery was found to be 98.82%. Voriconazole in plasma samples was stable when stored for different stability conditions. The method was found to be precise and accurate and can further be extended for pharmacokinetic studies for therapeutic drug monitoring of voriconazole in routine clinical practice.

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