HPLC法测定酒石酸托特罗定中左旋异构体的含量  

Determination of the S-enantiomer in Tolterodine Tartrate by HPLC

作　　者：王宇 何婷婷 黄巧巧 

机构地区：[1]浙江省食品药品检验研究院,杭州310052

出　　处：《海峡药学》2017年第11期71-73,共3页Strait Pharmaceutical Journal

摘　　要：目的改进并建立测定酒石酸托特罗定左旋异构体的高效液相色谱法。方法采用CHIRAL-AGP色谱柱(150mm×4.0mm,5μm),以0.02mol·L-1磷酸二氢钾溶液(用0.1mol·L-1氢氧化钠溶液调节pH值至6.5)-甲醇(75∶25)为流动相,流速0.5m L·min-1,检测波长为215nm。结果在上述色谱条件下,酒石酸托特罗定与其左旋异构体分离度良好,左旋异构体的定量限为0.4020μg·m L-1,在0.40~1.21μg·m L-1范围内线性关系良好(r=0.9993)。左旋异构体相对于酒石酸托特罗定的相对保留时间为1.2,校正因子为1.0。结论可用不加校正因子的主成分自身对照法测定酒石酸托特罗定中左旋异构体的含量。OBJECTIVE To improve and establish a method for determining S-enantiomer in tolterodine by HPLC. METHODS The determination was performed on a CHIRAL-AGP column （ 150mm ×4.0mm, and the mobile phase consisted of 0. 02mol· L-1 potassium dihydrogen phosphate flow rate of 1.0mL·min-1. The detection wavelength was 215nm. RESULTS solution-methanol （75： 25 An excellent separation tartrate 5μm） , ） at the was achieved for tolterodine tartrate and its enantiomer under the above column conditions. The LOQ was 0. 4020μg ·mL-1 for S-enantiomer,a good linearity was found in the range of 0. 40 ~ 1.21μg· mL-l（ r = 0. 9993 ）. The relative retention time between S-enantiomer and toherodine tartrate was 1.2 with a correction factor of 1.0. CONCLUSION The method is suitable for the determination of enantiomer in toherodine tartrate as the self-calibration method for main Component without adopting calibration factor.

关 键 词：酒石酸托特罗定 左旋异构体 高效液相色谱 方法改进 

分 类 号：R927[医药卫生—药学]