Development of Analstical Determination of Sildenafil Citrate Tablet
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Abstract
Sildenafil citrate is a selective PDE5 inhibitor which is widely used for erectile dysfunction at present. Consequently, the analytical method of sildenafil citrate is not available in the latest version of Pharmacopoeia. A couple of analytical methods of sidenafil citrate by UV and HPLC techniques were developed and validated. Methanol (10%) was an appropriate solvent for extraction of sildenafil citrate from pharmaceutical excipients for both techniques. The UV method with lmax at 292 nm showed linearity from 5-100 p.g/ml with within-day and between-day precision less than 0.46 and 3.87 %, respectively, accuracy as % recovery 101.16+3.23 %, LOD and LOQ at 100 and 340 ng/ml, respectively. The HPLC system was consisted of C18 column with a flow rate of mixture of acetonitrile and 0.1 M sodium acetate buffer pH 7.0 (70:30) at flow rate of 1.0 ml/m in as the mobile phase. lmax was set at 292 nm. The HPLC validation parameters were clearly expressed in linearity range 5-100 mg/ml with within-day and between-day precision less than 1.58 and 2.09 %, respectively, accuracy as % recovery 98.86+1.35 %, LOD and LOQ at 40 and 75 ng/ml, respectively.
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