Stability indicating

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.

A novel, simple, rapid and stability-indicating reversed-phase ultra performance liquid chromatographic method was developed and subsequently validated for quantitation of Emtricitabine (ECB) from drug substance matrix. The separation was achieved in less than 2.0 minutes on Waters ACQUITY UPLC BEH C18 (50 x 2.1) mm, 1.7µm column in isocratic mode with flow rate 0.25 mL/min. Mobile phase used was 0.015 M potassium dihydrogen phosphate buffer pH 2.2 and acetonitrile in ratio 75:25 v/v. Detection was carried out at the maximum wavelength of 284 nm using a photodiode array detector. The retention time of emtricitabine was 1.2 minutes. A forced degradation study was performed. Specificity of the method was established on drug substance by hydrolytic and oxidative stress conditions. Validation of analytical method was carried out as per the current ICH guidelines for linearity, recovery, precision, limit of detection, limit of quantification and robustness parameters.