차광 bag의 색상과 농도에 따른 Doxorubicin의 안정성

Abstract

This study was performed to evaluate the chemical stability of doxorubicin hydrochloride at concentration of 0.5 and 0.05 mg/mL in 0.9% sodium chloride injection, when stored in lightprotecting bags. The test samples were prepared in each concentration and then they were divided into three groups. Two groups were protected from light by light-protecting polyethylene bag - Group A(dark-brown color), Group B(jade/white double color) and one group was not protected from the normal fluorescent light-Group C. Chemical stability was assayed by HPLC initially and after 12, 24, 30 hours at room temperature. At 12, 24, 30 hours, the contents of doxorubicin hydrochloride 0.5 mg/mL were 92.69%, 88.35% and 79.90% for group A ; 91.67%, 86.09% and 76.82% for group B ; 89.75%, 83.73% and 76.40% for group C, respectively. At 12, 24, 30 hours, the contents of doxorubicin hydrochloride 0.05 mg/mL were 73.80%, 53.39% and 45.07% for group A ; 73.42%, 48.57% and 24.29% for group B ; 67.00%, 43.70% and 20.05% for group C, respectively. Doxorubicin hydrochloride 0.5 mg/mL in 0.9% sodium chloride injection was chemically stable(loss in potency of less then 10%) for 12 hours respectively, when stored in light-protecting polyethylene bag, while doxorubicin hydrochloride 0.05 mg/mL in 0.9% sodium chloride injection was unstable in all samples throughout the study. The greater rate of decomposition of doxorubicin hydrochloride occurred in the more diluted solution. In the same concentration, no significant difference of drug loss was observed between the groups of light-protecting polyethylene bags.