摘要
目的建立测定地塞米松磷酸钠注射液中地塞米松磷酸钠含量的高效液相色谱法,考察吸收不同强度的γ射线辐照后样品含量变化。方法将同一批号的样品放置于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。以0.75%三乙胺(磷酸调节pH至3.0)-甲醇(25∶75)为流动相,流速1 mL/min,检测波长242 nm,进样量20μL。结果方法质量浓度线性范围为5.0～12.0μg/mL(r=0.999 8);低、中、高3个质量浓度的平均回收率为100.902%,98.974%,100.518%,日间及日内精密度RSD均小于2%(n=3)。吸收1,2,4,8,16,25 kGy的辐照剂量后样品含量随着辐照强度的增加而明显下降,具有一定线性特征。结论所建立的方法可用于地塞米松磷酸钠注射液的含量测定。地塞米松磷酸钠注射液在辐照下具有不稳定性,且辐照对其含量影响显著。
Objective To develop a HPLC method for analyzing the content of dexamethasone sodium phosphate in Dexamethasone Sodium Phosphate Injection,and to investigate the dexamethasone sodium phosphate content changes in the sample after absorption of γ-ray irradiation in different intensity levels.Methods The samples of the same batch of Dexamethasone Sodium Phosphate Injection were put in the 60Co-γray radiation source for absorbing the radiation dose of 1,2,4,8,16,25 kGy by one-time.The mobile phase consisted of 0.75%triethylamine solution（adjusted pH to 3.0 by using phosphoric acid） ∶methanol（25 ∶75）,the flow rate was 1 mL/min,the detection wavelength was set at 242 nm and the injection volume was 20 μL.Results The linear range of dexamethasone sodium phosphate was 5.0-12.0 μg/mL（r=0.999 8）;the average recovery rates of the low,medium and high concentrations was 100.902%,98.974%and 100.518%;and inter-day（n=3） and intra-day precisions（n=3） were less than 2%.After absorption dose of 1 kGy,2 kGy,4 kGy,8 kGy,16 kGy,25 kGy by one-time,the sample content was decreased with the irradiation intensity increase and the Results showed certain linear characteristic.Conclusion The established method can be used for the content determination of Dexamethasone Sodium Phosphate Injection.Dexamethasone Sodium Phosphate Injection has the instability under radiation condition,and the irradiation has a significant impact on its content.
出处
《中国药业》
CAS
2013年第13期14-16,共3页
China Pharmaceuticals
关键词
地塞米松磷酸钠
辐照
含量测定
dexamethasone sodium phosphate
irradiation
content determination
