A dissolution test for capsules containing 50 mg of praziquantel and 500 mg of fenbendazole was developed and validated. The optimal conditions were an USP apparatus 2 with paddles rotating at 75 rpm, 900 mL dissolution medium (a mixture of 300 mL of ethanol and 600 mL 0.5 mol L-1 HCl), at 37.0 ± 0.5 °C. Both analytes achieved with sink conditions. A published high-performance liquid chromatography (HPLC) method was used to monitoring dissolution test during the optimization. Additionally, a chemometrics method based on UV-VIS spectrophotometry and partial least-squares (PLS) was developed and validated for the simultaneous determination of both analytes in the dissolution media. The coefficients of determination were 0.9986 and 0.9959 for fenbendazole and praziquantel, respectively, and the elliptical joint confidence region (EJRC) test concluded that constant and proportional biases were absent. The optimized model was applied to build dissolution profile and its results did not show statistical differences with HPLC method.
Keywords:
fenbendazole; praziquantel; dissolution test; partial least squares
