HPLC法测定齐多夫定及其注射液的含量及有关物质  

HPLC determination of content and related substances in zidovudine and injection

作　　者：华莲[1] 郝桂明[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2014年第4期1-4,共4页Tianjin Pharmacy

基　　金：2012年全球基金项目国家药品标准提高品种(No.GF2012-08/09)

摘　　要：目的：建立HPLC梯度洗脱法测定齐多夫定及其注射液的含量及有关物质.方法：采用岛津Shim-packCLC-ODS色谱柱（150 mm ×6.0 mm,5μm）,流动相A为甲醇,流动相B为水,按照时间程序进行梯度洗脱,流速为1.0ml/min,检测波长为215 nm,柱温为40℃.结果：杂质A和杂质C在0.2～50.0 μg/ml浓度范围内均与其峰面积呈良好的线性关系（r =0.999 9）,杂质A平均回收率为99.3％,RSD为1.4％（n=9）;杂质C平均回收率为98.2％,RSD为1.9％（n=9）;杂质B在0.4 ～ 50.0 μg/ml浓度范围内与其峰面积呈良好的线性关系（r=0.999 9）,平均回收率为95.8％,RSD为1.0％（n=9）;杂质D在0.2 ～ 25.0μg/ml浓度范围内与其峰面积呈良好的线性关系（r=0.9998）,平均回收率为106.8％,RSD为0.8％（n=9）;齐多夫定在0.4～ 50.0 μg/ml浓度范围内与其峰面积呈良好的线性关系（r=0.999 9）.结论：该方法在一个色谱系统中同时检出杂质A、B、C、D,重复性好,结果准确,可用于齐多夫定及其注射液的含量及有关物质测定.Objective： To establish a HPLC gradient elutioned method for evaluating the content and the related substances of zidovudine and injection. Methods ： Used Shim - pack CLC - ODS column （ 150 mm × 4.6 mm, 5 μm） , and the mobile phaseA was methanol, mobile phaseB was water, gradient elutioned, the flow rate was 1.0 ml/min with column temperature at 40 ℃. The detection wavelength was 215 nm. Results ：The assay displayed a good linearity of impurity A and C over the concentration range of 0.2 50.0 μg/ml（ r = 0. 999 9 ） , the average recoveries were 99.3% （ RSD was 1.4% , n = 9 ） and 98.2% （ RSD was 1.9% , n = 9 ）. A good linearity of impurity B over the concentration range of 0.4 - 50.0 μg/ml （ r = 0. 999 9 ） , the average recoveries were 95.8% （ RSD was 1.0%, n = 9 ）. A good linearity of impurity D over the concentration range of 0. 2 - 25.0 μg/ml （ r = 0. 999 8） ,the average recoveries was 106.8% （RSD was 0.8% , n = 9 ）. A good linearity of zidovudine over the concentration range of 0.4 -50.0 μg/ml（ r = 0. 999 9）. Conclusion： The method is simple, accurate and can be used to the determination of the content and impurity A、B、C and D in the same chromatographic system.

关 键 词：齐多夫定 注射液 杂质 质量控制 标准提高 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]