HPLC测定普瑞巴林含量

Determination of Pregabalin by HPLC

目的建立普瑞巴林的含量测定方法。方法以2,4,6-三硝基苯磺酸作为衍生化试剂,采用柱前衍生化HPLC。色谱柱为C18柱,流动相为0.01mol·L-1乙酸铵水溶液(用磷酸调pH至4.0)-乙腈(43∶57),流速为1.0mL·min-1;柱温为40℃;检测波长为350nm。结果回收率99.18%,RSD=1.15%,普瑞巴林在3.320～49.80μg·mL-1内呈良好线性关系(r=0.9999)。最低定量限:0.5μg·mL-1。结论所建立的方法快速、简便、准确、灵敏,可用于普瑞巴林的含量测定。

OBJECTIVE To establish an HPLC method for the determinaton of pregabalin. METHODS Samples were derivatized with 2,4,6-trinitrobenzene sulfonic acid （TNBSA）. Separation was achieved on a reversed-phase C18 column with the mobile phase of 0.01 mol·L^-1 ammonium acetate （ pH = 4.0） -acetonitrile （43：57 ）. The wavelength was 350 nm. RESULTS The average recovery was 99.18% , RSD = 1.15%. The calibration curve was linear between 3. 320-49.80 μg·mL^-1（r = 0. 999 9 ） , the limit of quantification was 0.5 μg·mL^-1 for pregabalin. CONCLUSION The method is simple, sensitive and praticable for the assay of pregabalin.