摘要
目的:建立香丹注射液中吐温80含量测定的方法,用于该类药品的质量控制和安全性评价。方法:采用高效液相色谱法,凝胶色谱柱,柱温为30℃;以0.02 mol/L醋酸铵溶液-乙腈(90∶10)为流动相,流速为0.6 mL/min;Alltech蒸发光散射检测器,漂移管温度120℃,氮气流速2.0 L/min,进样量10μL。结果:样品色谱图中吐温80无干扰,分离度符合要求,吐温80浓度在0.505~5.05 mg/mL范围内,线性关系良好(R^(2)=0.9991),加样回收实验表明,平均加样回收率96.7%, RSD=2.0%。结论:通过高效液相色谱法结合凝胶色谱柱建立的方法准确可靠,可以准确有效的检测香丹注射液中吐温80的含量,评价药品的安全性,控制药品质量。
ObjectiveTo establish a method for the determination of Xiangdan injection Twain 80 content,for the drug quality control and safety evaluation.MethodsThe gel chromatography column,the column temperature is 30 DEG C;to 0.02 mol/L ammonium acetate solution and acetonitrile(90∶10)as mobile phase.The flow rate was 0.6 ml/min;Alltech evaporative light scattering detector,the drift tube temperature of 120 DEG C,nitrogen flow rate 2.0 L/min,into 10 mu l of sample volume.ResultsThe Twain80 concentration in the range of 0.505-5.05 mg/mL,a good linear relationship(R^(2)=0.9991),the average recovery rate was96.7%,RSD=2.0%.ConclusionThe established method is accurate and reliable,and can effectively detect Xiangdan injection of Tween 80 in the content and evaluation of drug safety and control the quality of drugs.
作者
巩晓宇
严俊珍
邱凤邹
陈秋燕
陆燕萍
GONG Xiaoyu;YAN Junzhen;QIU Fengzou;CHEN Qiuyan;LU Yanping(Longgang District People's Hospital of Shenzhen&The Second Affiliated Hospital of the Chinese University of Hong Kong,Shenzhen 518172,China)
出处
《中国民族民间医药》
2022年第3期38-40,45,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
