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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 a method for the determination of pregabalin. Methods 2,4,6 - trinitrobenzene sulfonic acid as a derivatization reagent, using pre-column derivatization HPLC. The column was C18 with the mobile phase of 0.01mol·L-1 ammonium acetate (adjusted to pH 4.0 with phosphoric acid) -acetonitrile (43:57) and the flow rate was 1.0mL · min-1. The column temperature was 40 ℃. The wavelength is 350 nm. Results The recovery rate was 99.18% with RSD = 1.15%. Pregabalin had a good linear relationship (3.399 ~ 0.9999) in the range of 3.320 ~ 49.80μg · mL-1. The limit of quantification: 0.5μg · mL-1. Conclusion The established method is rapid, simple, accurate and sensitive and can be used for the determination of pregabalin.