Validated Method for Tadalafil Analysis in Pharmaceutical Preparations by Capillary Electrophoresis

摘要

A simple, rapid and inexpensive capillary electrophoretic method has been developed and validated for the determination of tadalafil in pharmaceutical preparations. The analysis was carried out using a fused silica capillary (60 cm × 75 μm I.D.), phosphate buffer (50 mM, 3.0 pH) as back ground electrolyte (BGE), 15 kV applied voltage with UV detection at 254 nm and at a working temperature of 23 ± 1 °C. Linearity was observed in the concentration range from 200–5000 μg/mL, with a correlation coefficient (R2) of 0.9998 and 200 μg/mL as the limit of detection. The percentage recovery of tadalafil from pharmaceutical preparations was 99.5. Validation parameters prove the precision of the method and its applicability for the determination of tadalafil in pharmaceutical tablet formulations. The method is fast and is suitable for high throughput analysis of the drug.