Fabric phase sorptive extraction combined with high-performance liquid chromatography-photodiode array detection for the determination of tazarotene in gel dosage forms.

Abstract

Tazarotene, a member of the acetylenic class of retinoids, is a third-generation prescription topical retinoid sold as a cream, gel, or foam. In its gel or cream formulations, tazarotene is at a concentration of either 0.1 % or 0.05 %. Fabric phase sorptive extraction membranes are used to selectively isolate and preconcentrate target analytes from different sample matrices. In this study, the tazarotene gel formulation was directly applied to fabric phase sorptive extraction membranes and extracted through a mixture of acetonitrile and water (80:20, v/v) to obtain a clean product free of colloidal suspension of tazarotene gel formulation. The final solutions were injected into an HPLC system equipped with a Zorbax 5 μm Phenyl-Hexyl LC Column (250 × 4.6 mm). Injection volume was 50 μL and UV detection was performed at 326 nm. The flow rate was 1.0 mL min-1 while using an isocratic elution with a mixture of ammonium acetate (50 mM) and methanol (15:85, v/v) as the mobile phase. The method was validated according to ICH guideline Q2 (R1) and successfully applied to gel formulations including 0.01 % tazarotene. This is the first reported application of fabric phase sorptive extraction in the analyses of gel formulations. The capability of fabric phase sorptive extraction membranes to clean up the sample matrix and prepare active pharmaceutical ingredients to be analyzed with acceptable recovery (>98.0 %) and reproducibility may encourage quality control laboratories to use fabric phase sorptive extraction in routine applications.