Abstract
Objective: The popularity of Sildenafil, the widespread distribution of various products and dietary supplements with added synthetic drugs, requires reliable analysis methods. This research study aimed to develop a simple isocratic HPLC method for the determination of Sildenafil in tablet dosage forms from the local market.
 Methods: Separation was carried out at 30 °C, using column LiChrosorb® RP-18 (150 x 4.0 mm, 5 μm) with mobile phase consisting of acetonitrile: methanol: 0.5% triethylamine (15: 26: 59 v/v/v). The detector was set at 290 nm. The flow rate was 1.0 ml/min and the injection volume was 20 μl.
 Results: Linear correlation was obtained within the range 6.25–50.0 μg/ml with correlation coefficient (R2) 0.9998. The achieved limits of detection and quantitation were 0.7 and 2.2 μg/ml, respectively.
 Conclusion: The developed method can be applied for the quality control of Sildenafil preparations.
Highlights
Most of erectile dysfunction treatment approaches are based on phosphodiesterase inhibitors [3]
Sildenafil citrate (chemically known as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl1H-pyrazole [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4methyl piperazine citrate) is a potent and selective phosphodiesterase inhibitor. It is the first phosphodiesterase inhibitor introduced on the market (Viagra®, Pfizer) [4]
Various analytical techniques like spectrophotometry [9, 11], Raman spectroscopy [11, 12], thin layer chromatography [13], high performance liquid chromatography [14,15,16,17,18,19,20,21,22,23], high performance liquid chromatography-mass spectrometry [24,25,26,27] are reported for Sildenafil determination in pharmaceutical preparations [10, 12, 1820, 22, 23, 25], biological samples [16, 20, 21, 24,25,26,27], dietary supplements [3, 5, 13], herbal products [15] and drinks [11]
Summary
The popularity of Sildenafil, the widespread distribution of various counterfeit products and dietary supplements with added synthetic drugs requires analysis methods for analysis. Various analytical techniques like spectrophotometry [9, 11], Raman spectroscopy [11, 12], thin layer chromatography [13], high performance liquid chromatography [14,15,16,17,18,19,20,21,22,23], high performance liquid chromatography-mass spectrometry [24,25,26,27] are reported for Sildenafil determination in pharmaceutical preparations [10, 12, 1820, 22, 23, 25], biological samples [16, 20, 21, 24,25,26,27], dietary supplements [3, 5, 13], herbal products [15] and drinks [11]. This article presents the development of a simple isocratic HPLC method for the determination of Sildenafil in tablet dosage forms obtained randomly from the local market.
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