A Novel High-performance Liquid Chromatography Method with Fluorescence Detection for the Quantification of Roflumilast in Tablet Formulations

Abstract

Objective:This study aims to develop and validate a novel high-performance liquid chromatography method with fluorescence detection for quantifying roflumilast in tablet formulations.Methods:Separations were achieved by a C18 analytical column (250x4.6 mm, 5 μm) at 40 ºC. Isocratic elution accompanied by a mobile phase comprising 20% aqueous o-phosphoric acid solution (0.08%) and 80% methanol was applied. The excitation and the emission wavelengths were 290 and 380 nm, respectively.Results:The linear range was 1.25-10.00 μg/mL. Irbesartan was used as the internal standard. The limits of detection and quantification were 0.07 μg/mL and 0.22 μg/mL, respectively. The precision and accuracy of the method was determined at the concentrations of 1.25, 5.00 and 10.00 μg/mL. The recovery percentage was calculated by the tablet solutions spiked at low, middle and high concentrations. The robustness of the method was tested in terms of flow rate, mobile phase composition and column temperature.Conclusion:The proposed method was successfully applied for determining roflumilast in tablet formulations with a high precision and accuracy.

Keywords

• fluorescence
• hplc
• method development
• roflumilast
• validation