辐照对呋塞米注射液含量的影响考察

Effects of Irradiance on the Content Changes of Furosemide Injection

目的:建立测定呋塞米注射液中呋塞米含量的方法,并考察呋塞米注射液吸收不同强度的γ射线辐照后含量的变化。方法:采用高效液相色谱法测定含量,色谱柱为Diamonsil Technology C18,流动相为甲醇-0.1%磷酸(60∶40),流速为1 mL.min-1,检测波长为286 nm。将同一批号的呋塞米注射液制备成20μg.mL-1溶液后放置于60Co-γ射线放射源中,一次性吸收1、2、4、8、16、25 kGy的辐照剂量后检测药物含量。结果:呋塞米检测浓度线性范围为6～24μg.mL-(1r=0.999 7);低、中、高浓度的平均回收率分别为100.15%、101.52%、101.35%;日间及日内RSD(n=3)均小于2%;当吸收辐照剂量在2 kGy以上时样品含量变化较大,2、4、8、16、25 kGy辐照后含量分别约为18、17、14、11、7μg.mL-1,辐照强度增加与含量下降呈线性关系(r=0.986 2)。结论:所建立的高效液相色谱法可用于呋塞米注射液的含量测定;辐照对呋塞米注射液的稳定性具有显著影响。

OBJECTIVE： To develop a method for the content determination of furosemide in Furosemide injection, and to study the content changes of Furosemide injection after absorbing y-ray irradiance in different intensity levels. METHODS： HPLC method was adopted. The determination was performed on Diamonsil Technology C^8 column with mobile phase consisted of metha- nol-0.1 % phosphoric acid （60：40） at the flow rate of 1 mL.min ~. The detection wavelength was set at 286 nm. Same batch of Fu- rosemide injection was prepared into 20μg·mL-1 solution and then put in the 6Co-y ray. The content of furosemide was determirled after absorbing the radiation dose of 1, 2, 4, 8, 16, 25 kGy for one time. RESULTS： The linear range of furosemide was 6-24μg·mL-1 （r=0.999 7） with low, medium and high concentrations average recoveries of 100.15%, 101.52% and 101.35% ; and in- ter-day and intra-day RSD were less than 2% ; the content changes of injection had more difference at irradiance dose of above 2 kGy. The contents of furosemide were 18 μg·mL-1, 17μg·mL-1, 14 μg·mL-1, 11 μg·mL-1and 7 μg·mL-1 at irradiance doses of 2, 4, 8, 16, 25 kGy, respectively. The increase of irradiance density showed a linear relationship with the decrease of content （r= 0.986 2）. CONCLUSION： The developed HPLC can be used for the content determination of Furosemide injection; and the irradi- ance has a significant impact on the stability of Furosemide injection.