Development and Validation of a Dissolution Test Method for Albendazole and Praziquantel in Their Combined Dosage Form

SILVANA E. VIGNADUZZO; MARÍA A. OPERTO; PATRICIA M. CASTELLANO

JOURNAL OF THE BRAZILIAN CHEMICAL SOCIETY

SOC BRASILEIRA QUIMICA

Lugar: San Pablo; Año: 2015 vol. 26 p. 729 - 735

0103-5053

A dissolution test method and an analytical procedure by HPLC were developed and validated for the evaluation of the dissolution of tablets containing albendazole and praziquantel. Two differentcommercially tablets containing 500 mg of albendazole and 50 mg of praziquantel for veterinary use were selected for this study. A dissolution medium containing a mixture of 300 mL ethanol and 600 mL of 0.1 mol L-1 HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium and 75 rpm were fixed. Dissolution profiles were generated at 45 min.Dissolution samples were analyzed with a reversed-phase high-performance liquid chromatography (RP-HPLC) method with ultraviolet (UV) detection at 210 nm, developed and validated for this purpose. Each product was also assayed for analyte content according to USP 35. The dissolution test described here could be proposed as a means of assessing finished product quality.