辐照对呋塞米注射液含量的影响考察

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。

Effects of Irradiance on the Content Changes of Furosemide Injection

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 γ-ray irradiance in different intensity levels.METHODS:HPLC method was adopted.The determination was performed on Diamonsil Technology C18 column with mobile phase consisted of methanol-0.1% phosphoric acid(60:40) at the flow rate of 1 mL·min-1.The detection wavelength was set at 286 nm.Same batch of Furosemide injection was prepared into 20 μg·mL-1 solution and then put in the 60Co-γ ray.The content of furosemide was determined after absorbing the radiation dose of 1,2,4,8,16,25 kGy for one time.RESULTS:The linear range of furosemide was 6～24 μg·mL-1(r=0.999 7) with low,medium and high concentrations average recoveries of 100.15%,101.52% and 101.35%;and inter-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-1,17 μg·mL-1,14 μg·mL-1,11 μg·mL-1 and 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 irradiance has a significant impact on the stability of Furosemide injection.