Stability indicating RP-HPLC method development and validation of Sildenafil Citrate in pure form

Abstract

A simple, selective, precise, sensitive and stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the analysis of sildenafil citrate in pure form. Chromatographic separation achieved isocratically on Inertsil ODS-3V (4.6 x 250) mm, 5µ column utilizing a mobile phase of water: acetonitrile (40:60)%v/v with flow rate of 1ml/min with UV detection at 214 nm at ambient temperature. The retention time was 6.91 min. The method is accurate (100.32 ± 0.84), precise (100.4 ± 1.04) and linear (R²=0.999) within the range of 20% - 150% of standard drug concentration. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0177 µg/ml and 0.0535 µg/ml respectively. Stress studies were carried out as per recommendations of ICH guidelines. The method was proved to be robust with respect to change in flow rate, mobile phase composition and column oven temperature. Solution stability was found to be more than 8 hrs.