RP-UPLC.

This study is aimed at Developing and validating an UPLC method for determination of Sildenafil and tadalafil content in API and formulations. A chromatographic system consisting Waters  Acquity UPLC BEH C8(1.8 µm)column, mobile phase of  0.2 M ammonium acetate and Acetonitrile with gradient elution at flow of 0.3 mL/min and UV detector set at 245 nm has shown a good chromatographic separation for Sildenafil tadalafil. The developed method was validated as per ICH Guidelines, the developed UPLC method has run time of only 10 minutes making the method productive and tested by spiking all the impurities of sildenafil and tadalafil. It may be applied for Quality control Testing.

This study is aimed at Developing and validating an UPLC method for the related substances of Sildenafil that might coexist in tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters  Acquity UPLC HSS C18(1.8 µm)column, mobile phase of  ammonium acetate and Acetonitrile with gradient elution at flow of 0.3 mL/min and UV detector set at 245 nm has shown a good chromatographic separation for Sildenafil and its related substances. The developed method was validated as per ICH Guidelines and compared with Pharma Europa method. The pharmacopeia method has above 60 minutes runtime to separate all the listed related compounds, the developed UPLC method has run time of only 10 minutes making the method productive and may be applied for Quality control Testing.