HPLC-UV测定法测定多西他赛注射液药物含量

Determination of docetaxel in docetaxel injection by HPLC-UV

目的:建立HPLC-UV法测定多西他赛注射剂中多西他赛含量。方法:采用COSMOSIL 5C18-MS-II色谱柱(5μm,250mm×4.6 mm),以0.1%磷酸水溶液(A)-乙腈(B)为流动相,等度洗脱,流速1.0 m L/min,柱温30℃,紫外检测波长230 nm。结果:在选定条件下,多西他赛峰与内标紫杉醇峰分离良好,两者峰面积之比与多西他赛浓度在0.5~32μg/m L范围内具有良好线性关系,r=0.9999;平均回收率在100.1%~103.9%,RSD<3.7%。结论:经方法学验证表明,该方法可用于多西他赛注射液中药物含量测定。

Objective： To establish an HPLC-UV method for determining docetaxel in docetaxel injection. Methods： The separation was performed on the COSMOSIL 5C18-MS-II（ 4. 6mm × 250 mm,5μm）. The mobile phase consisted of 0. 1% mol / L phosphoric acid（ A） and acetonitrile（ B） with an isocratic elution at a flow rate of 1. 0m L/min. The column temperature was 30℃,and the detection wavelength was at 230 nm. Results： Under the described condition,docetaxe was completely separated from paclitaxel. Good linear relationship was observed between the peak area ratio of docetaxel and paclitaxel and concentration in the range of 0. 5 ~ 32μg / m L,r =0. 9999. The average recovery of docetaxel ranged from 100. 1% to 103. 9%. The relative standard deviations were less than 3. 7%.Conclusion： It is confirmed by the methodology validation that the quantification method is applicable to the quality control of docetaxel of docetaxel for injection.