摘要
目的建立高效液相色谱法测定卡培他滨含量及有关物质的方法。方法采用C18柱，以B（甲醇：乙腈：0．1％醋酸=7：0．2：12．8）-C（甲辟：乙腈：0．1％醋酸=16：1：3）为流动相，梯度洗脱，流速为1．OmL·min-1，进样量为10μL，检测波长为250nm，柱温为40℃，自动进样室为5℃。结果在浓度为0．0997-0．997mg·mL-1范围内线性关系良好（r=0．9999，n=6），检测限为0．020μg·mL^-1。该方法能够分离卡培他滨及其有关物质。结论本方法灵敏、准确、专属性及重复性好。可用于卡培他滨的含量测定及有关物质限量检查。
OBJECTIVE To establish a HPLC method for the determination of the content and related sub- stances of Capecitabine. METHODS C18 column was used, the mobile phase was B（ methanol ： acetonitrile： 0.1% acetic acid = 7： 0.2：12.8）-C（methanol： acetonitrile： 0.1% acetic acid = 16：1 ： 3） by gradient elution, the flow rate was 1.0mL-min-1. The injection volume was 10μL, detection wavelength was set at 250nm, the column tempera- ture was 40℃ and the automatic sampling temperature was 5℃. RESUTLS The calibration curve was linear in the range of 0. 0997-0. 997mg.mL- 1, r= 0. 9999（n = 6） ; the limit of detection was 0. 020μg.mL- 1. The related substances were completely separated from Capecitabine by using this method. CONCLUSION With good sensi- tivity, accuracy, selectivity and reproducibility, the method is applicable for the determination of Capecitabine and its related substances.
出处
《海峡药学》
2013年第1期48-51,共4页
Strait Pharmaceutical Journal
