HPLC法测定多西他赛注射液的含量

目的:建立多西他赛注射液含量的测定方法。方法:采用高效液相色谱法,色谱柱为Waters Sunfire C18柱(250×4.6mm,5μm),梯度洗脱方法,流速为1.0mL/min;检测波长为232nm,柱温40℃。结果:多西他赛的浓度在70～120μg/mL范围内线性关系良好(y=234.46x+137.48 R=0.999),方法的最低检测限为0.8ng(S/N=3.1);高、中、低3种浓度的平均回收率(n=3)100.4%(RSD=0.77%);日间精密度RSD=0.60%(n=6),各杂质峰与主峰达到基线分离。结论:此法操作简单,灵敏、准确、重复性好,适用于多西他赛注射液的含量测定。

Detemination of Assay of Decetaxel Injection by HPLC

Objective:To establish a method for determining the assay of Docetaxel Injection.Methods: By application of high performance liquid chromatography,column is a Waters Sunfire C18 column(250 × 4.6 mm,5 μm),gradient elution,the flow rate is 1.0mL/min;detection wavelength is 232nm,column temperature is 40 ℃.Results: Docetaxel concentration in the range of 70 ～ 120μg/mL linear relationship is good(y = 234.46x + 137.48 R = 0.999),the method limit of detection is 0.8ng(S / N = 3.1);high,medium,low average recoveries of three concentrations(n= 3) 100.4%(RSD = 0.77%);inter-day precision RSD = 0.60%(n = 6),each impurity peak and the main peak baseline separate.Conclusion:This method is simple,sensitive,accurate,reproducible,and apply to docetaxel injection Determination.