HPLC法测定枸橼酸坦度螺酮片含量和有关物质  

Determination of contents and related substance in citrate tandospirone tablets by HPLC

作　　者：李婧[1] 何黎黎[1] 仇丽颖[1] 李佳川[1] 

机构地区：[1]西南民族大学,四川成都610041

出　　处：《西南民族大学学报（自然科学版）》2016年第2期183-187,共5页Journal of Southwest Minzu University(Natural Science Edition)

摘　　要：采用高效液相色谱法,用Luna C_(18)柱(250×4.6mm,10μm),以乙腈-0.01mol·L^(-1)磷酸二氢钾溶液(35:65,pH3.0)为流动相,流速:1ml/min,柱温:25℃,进样量20μL,检测波长:239nm.在该色谱条件下枸橼酸坦度螺酮和杂质峰达到良好分离(R>1.5),枸橼酸坦度螺酮在1.0~200.0μg·ml^(-1)范围内线性关系良好(r=0.9991);重复性及精密度良好(RSD<2%),3种浓度的平均回收率分别为100.17%、99.03%及99.75%(n=3).方法快速、简便、准确,适用于枸橼酸坦度螺酮片的含量测定和有关物质检查.A HPLC method was employed in this study using a Luna C_（18） column（250 × 4. 6mm,10μm）,and the mobile phase was acetonitrile ：0. 1 mol·L^（-1） KH_2PO_4 buffer solution（35：65,pH 3. 0）. The flow rate was 1. 0 m L·min^（-1）,the column temperature was 30 ℃ and the UV detection was set at 239 nm. Under this condition,Tandospirone tablets were separated with its related substances thoroughly（ R 〉1. 5）. The calibrated linear curve of tandospirone was within 1. 0 μg·ml^（-1） to 200. 0μg·ml^（-1）（r = 0. 9991）. The precision and reproducibility of the method were good（RSD 〈2%）. The recovery rates for three concentrations were 100. 17%,99. 03% and 99. 75%（ n = 3）,respectively. This method is quick,simple and effective,and is suitable for the determination of citrate tandospirone content and related substance in the tablets.

关 键 词：高效液相色谱法 枸橼酸坦度螺酮 含量测定 

分 类 号：O657.7[理学—分析化学] R917[理学—化学]