HPLC法测定五种不同厂家多西他赛注射液含量的研究

Content determination of docetaxel injection from five different manufacturers by high performance liquid chromatography technology

目的建立一种快速、便捷、准确的高效液相色谱(HPLC)技术,检测多西他赛(Docetaxel)注射液内Docetaxel的含量,旨在对临床不同厂家Docetaxel注射液开展质量控制,指导临床安全有效的用药。方法所用色谱柱为GL wonda sil C18(粒径、内径与长度依次为5μm、4.6 mm、15 cm)。将水溶液(A)-乙腈(B)当做流动相,设定1.0 mL·min^(-1)流速,30℃柱温,进样量0.01 mL,232 nm测定波长。结果Docetaxel在0.2~20μg·mL^(-1)浓度范围时表现出良好的线性关系(Y=0.0439 X+0.01,且r^(2)值为0.999)。稳定性、专属性、回收率与精密度验证结果与有关规定相符。测得临床常用的5个不同厂家的多西他赛含量分别为(104.93±3.51)%、(98.40±0.01)%、(109.45±7.78)%、(109.55±0.71)%及(105.05±2.12)%,均符合质量要求。结论建立的HPLC技术专属性强、便于操作、灵敏度高、准确,对临床不同厂家Docetaxel注射液内药物含量可做出快速准确检测,同时给予评价。

Objective High performance liquid chromatography(HPLC)was established to determine the content of docetaxel in docetaxel injection in order to control the quality of docetaxel and to ensure the rational use of the drug.Methods The separation was performed on the GL wonda sil C18(150×4.6 mm,5μm).The mobile phase was consisted of acetonitrile and water with gradient elution at a flow rate of 1.0 mL·min-1,column temperature at 30℃,and the sample volume was 10μL.The UV detection wavelength was set at 232 nm.Results Docetaxel had a good linearity in the range of 0.2~20μg·mL^(-1)(Y=0.0439 X+0.01,r^(2)=0.999).The results of stability,specificity,recovery and precision were in accordance with the relevant regulations.The content of docetaxel in five d ifferent clinical manufacturers were(104.93±3.51)%,(98.40±0.01)%,(109.45±7.78)%,(109.55±0.71)%and(105.05±2.12)%.Conclusion The established HPLC method is simple,accurate,sensitive and specific,and can quickly determine and evaluate the drug content in docetaxel injection.