Rapid Determination of Sildenafil Citrate in Pharmaceutical Preparations Using Monolithic Silica HPLC Column

Abstract

Abstract A simple, rapid, and sensitive high performance liquid chromatography (HPLC) method has been developed and validated for the determination of sildenafil citrate in pharmaceutical preparations. The method was developed utilizing a 100 × 4.6 mm I.D. monolithic silica column and an isocratic elution of 60:40, v/v acetonitrile/water. The elution of the analyte was monitored at 292 nm with a flow rate of 2.0 mL/min. All analyses were conducted at ambient temperature. Linearity was observed in the concentration range from 50–3000 ng/mL, with a correlation coefficient (R 2) greater than 0.999. The limit of detection was 25 ng/mL. Parameters of validation prove the precision of the method and its applicability for the determination of sildenafil citrate in pharmaceutical tablet formulations. The method is fast (less than 1 min) and is suitable for high throughput analysis of the drug.