摘要
目的:建立测定他克莫司滴眼液含量的高效液相色谱法。方法:以高效液相色谱法(HPLC)测定他克莫司含量,Agilent SB-CN柱为色谱柱;流动相乙腈:0.1磷酸=35:65(V/V),柱温40℃,流速2mL/min,紫外检测波长210nm。结果:在0.0248~0.2480mg/mL范围内(r=0.9997),他克莫司峰面积和质量浓度呈良好线性关系,平均回收率为99.0%,RSD为0.79%。3批他克莫司滴眼液含量分别为99.3%、99.6%、100.1%。结论:该含量测定方法准确度高,操作简便,检测结果具有较高稳定性,专属性强,在制剂质量控制中有明显效果。
Objective:To establish a HPLC method for the determination of tacrolimus eye drops.Methods:The content of tacrolimus was determined by HPLC with Agilent sb-cn as the column,acetonitrile as the mobile phase:0.1 phosphoric acid=35:65(V/V),column temperature 40℃,flow rate 2 m L/min,UV detection wavelength 210 nm.Results:In the range of 0.0248~0.2480 mg/m L(r=0.9997),there was a good linear relationship between the peak area of tacrolimus and the mass concentration,with an average recovery of 99.0%and RSD of 0.79%.The contents of three batches of tacrolimus eye drops were 99.3%,99.6%and 100.1%respectively.Conclusion:The method has high accuracy,simple operation,high stability and specificity,and has obvious effect in the quality control of preparations.
作者
陈宇翔
王娟
魏宗有
陈忠
陈韡彬
江宁宇
CHEN Yu-xiang;WANG Juan;WEI Zong-you;CHEN Zhong;CHEN Wei-bin;JIANG Ning-yu(Fujian Institute of Microbiology,Fujian Fuzhou 350007)
出处
《中国医疗器械信息》
2020年第3期14-14,106,共2页
China Medical Device Information
