Effects of ingredients on stability of captopril in extemporaneously prepared oral liquids

Abstract

The stability of captopril in several extemporaneously prepared oral liquid formulations was studied. Captopril 1 mg/mL oral liquid formulations were prepared from either powder or tablets in two grades of water syrup, methylcellulose, and edetate disodium. The liquids were stored at 5 °C in amber glass containers, and samples were removed at intervals up to 30 days for assay of captopril concentration by stability-indicating high-performance liquid chromatography. The pH of the formulations remained fairly stable for 30 days. In general, captopril was more stable in formulations containing captopril from tablets than from powder. Captopril in formulations in which the only vehicle was highly purified water was slightly but not significantly more stable than in formulations made with sterile water for irrigation. Formulations made with undiluted syrup were more stable than formulations in which water was used to dilute syrup or formulations containing methylcellulose. The formulations containing edetate disodium were much more stable than those that lacked this component. The stability of captopril 1 mg/mL in oral liquid formulations was influenced by the captopril source (tablets versus powder) and by the presence of syrup, methylcellulose, and edetate disodium. Captopril in a preparation made with tablets and undiluted syrup was stable for 30 days at 5 °C and the formulation should be palatable.