Srihari Molleti

This study is aimed at Developing and validating an UPLC method for Bosentan and its related substances that might coexist in bulk drugs and its tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters Acquity UPLC HSS PFP, 2.1x 50mm (2.5 µm) column, mobile phase of 0.02M KH2PO4with pH 2.0 as Buffer phase and Acetonitrile: Methanol in 1:1 ratio as organic phase, with gradient elution at flow of 0.6 mL/min and UV detector set at 220 nm has shown a good chromatographic separation for Bosentan and its related substances. The developed method was validated as per ICH Guidelines and shown equivalency with API Vendor method. The developed UPLC method has run time of only 13 minutes making the method productive and may be applied for Quality control Testing.

This study is aimed at Developing and validating an UPLC method for Sildenafil citrate, Bosentan and its related substances that might coexist in bulk drugs and its tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters Acquity UPLC HSS PFP, 2.1x 50mm (2.5 µm) column, mobile phase of 0.02M KH2PO4with pH 2.0 as Buffer phase and Acetonitrile: Methanol in 1:1 ratio as organic phase, with gradient elution at flow of 0.4 mL/min and UV detector set at 220 nm has shown a good chromatographic separation for sildenafil citrate, Bosentan and its related substances. The developed method was validated as per ICH Guidelines. The developed UPLC method has run time of only 20 minutes making the method productive and may be applied for Quality control Testing.

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 febuxostat and its related substances that might coexist in bulk drugs and its 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 with pH 4.5 as Buffer phase and Acetonitrile: Methanol in 1:1 ratio as organic phase, with gradient elution at flow of 0.4 mL/min and UV detector set at 315 nm has shown a good chromatographic separation for Febuxostat and its related substances. The developed method was validated as per ICH Guidelines and shown equivalency with API Vendor method. The developed UPLC method has run time of only 10 minutes making the method productive and 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.