A NEW VALIDATED METHOD FOR DETERMINATION OF ROFLUMILAST IN TABLET BY CZE-UV

This paper reports a new and validated capillary electrophoresis method to determine Roflumilast (RFL) with an internal standard in tablet. The separation was made on an uncoated fused-silica capillary column 50 cm effective length and 75 µm i.d. 20 mmol L-1 of Na2B4O7 buffer including 15% (v/v) methanol (pH=9.5) was used as background electrolyte. A potential of 20 kV was applied. The developed method was linear in the range of 0.75 µg mL-1 and 15.0 µg mL-1. LOQ and LOD values were 0.074 µg mL-1 and 0.022 µg mL-1 for inter-day, respectively. The precision value was 0.78% for inter-day. The accuracy was between 98.63 and 100.97 as recovery. This study was the first report for the determination of RFL in Daxas® solid dosage form using CE. The validated method was found as rapid, cheap, easy to apply and uses small sample volume, very little organic solvent, and high efficiency and resolution.