羟丙基-磺丁基-β-环糊精包合物冻干粉中多烯紫杉醇的含量及其有关物质测定___

Abstract Objective：To establish an RP-HPLC method for determination ofdocetaxel and its related substances in inclusion complex. Method：The separation was performed on a Dikma Platisil C₁₈ column(150 mm×4.6mm，5μm)．The column was remained at 30℃ and the UV detector was set at 227 nm. When related substances were detected , using acetonitrile- water（40:60，v:v）as mobile phase A and acetonitrile as mobile phase B to carry out gradient elution at a flow rate 1.5 mL·min^-1.And to determine the content, using acetonitrile- water（60：40，v:v）as mobile phase to carry out isometric elution at a flow rate 1.0mL·min^-1, Paclitaxel was used as internal standard. Result: Docetaxel and its related substances could be baseline separated. A linearity between the peak area ratio of docetaxel/ internal standard and docetaxel concentration was achieved in the range of 0.05~100μg·mL^-1 withr=0.9993.The average recovery was 100.1％（n=9）.The limit of detection was 0.01μg·mL^-1（S/N=3）.Conclusion：This method is sensitive ,accurate and satisfactory in the separable effect, and can be used for quality control of docetaxel inclusion complex．