Assays of active ingredient content and dissolution of oral dosage forms containing amoxicillin and sulbactam pivoxil using a new HPLC method

MARIELA RAZUC; FERNANDA CABRERA; MARIANO GARRIDO; MARÍA VERÓNICA RAMÍREZ RIGO

Córdoba

Congreso; 6ta Reunión Internacional de Ciencias Farmacéuticas; 2021

Universidad Nacional de Córdoba

Amoxicillin(AMO)/sulbactam pivoxil(SP) are commercialized in solid oral forms. This combination has not been referred by any pharmacopoeia. In literature there aren’t any dissolution study regarding AMO/SP and there is only one study devoted to their determination in tablets, where formulations with AMO/SP ratio of 1:1 are analyzed. The purpose of the present work is to develop a dissolution study of AMO/SP formulations and determine both analytes in oral forms using a new HPLC/UV method, even in the most challenged AMO/SP ratio (7:1). The HPLC method used a reverse phase C18 column with a mobile phase consisting of acetonitrile and water (80:20 v/v) in isocratic mode. The samples analyzed were oral tablets and suspensions (AMO/SP ratio 1:1-7:1). The dissolution study was carried out testing several media of sodium lauryl sulfate, polysorbate 20 and polysorbate 80. The conditions used were: apparatus II at 75rpm, 900mL of medium and a temperature of 37±0.5°C. The maximum dissolved percentages achieved (99% for AMO and 91% for SP) were obtained when polysorbate 20 at 0.10 gr% w/v was used as medium. The HPLC method used was found suitable for determining AMO and SP (recovery 91.2-100%) in tablets and oral suspensions, even in formulations where the AMO/SP ratio was as high as 7:1.