An HPLC method for the determination of digoxin in dissolution samples

Miroslav Milenkovic, Valentina Marinkovic, Predrag Sibinovic, Radosav Palic, Dragan Milenovic
2010 Journal of the Serbian Chemical Society  
An HPLC method for digoxin quantification in dissolution samples obtained as per the official British Pharmacopeia (BP) method is presented in this paper. The chromatography was performed at 20 °C on a Symmetry C18; 3.5 μm, 75 mm×4.6 mm column with water-acetonitrile (72:28, v/v), as the mobile phase and UV detection at 220 nm. The method was found to be selective, linear, accurate and precise in the specified ranges. The LOD and LOQ were 0.015 and 0.050 µg mL -1 , respectively. Robustness
more » ... ly. Robustness testing was conducted to evaluate the impact of minor changes in the chromatographic parameters (i.e., acetonitrile fraction, flow rate of the mobile phase, column temperature and column length) on the characteristics of the digoxin peak. A full factorial design (2 4 ) was used to investigate the influence of the four variables The presented HPLC method was applied in quality and stability testing of digoxin tablets 0.25 mg.
doi:10.2298/jsc100106123m fatcat:pc7k5lbeyrdnxnigj3ei6wvdcy