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目的:建立普瑞巴林及其有关物质[副产物:(4S)-异丁基-γ-丁内酰胺和拆分试剂:(S)-(+)-扁桃酸]的HPLC测定方法。方法:采用Lichrospher-C18色谱柱(250mm×4.6mm,5μm);流动相为甲醇-乙腈-20mmol.L-1磷酸盐缓冲液(pH7.0)(350∶100∶550);流速1.0mL.min-1;检测波长210nm。结果:普瑞巴林的线性范围为600.9～1 402.1mg.L-1,r=0.999 9;副产物的线性范围为2.99～6.97mg.L-1,r=0.999 2;折分试剂的线性范围为0.61～1.42mg.L-1,r=0.999 9。三者的最低检测量分别为2.8,10.0,2.0ng,且普瑞巴林与各杂质分离良好。结论:本法简便快速,灵敏度高,专属性好,准确可靠。
OBJECTIVE: To establish an HPLC method for the determination of pregabalin and its related substances [byproduct: (4S) -isobutyl-γ-butyrolactam and resolving agent: (S) - (+) - mandelic acid]. Methods: Lichrospher-C18 column (250mm × 4.6mm, 5μm) was used. The mobile phase was methanol-acetonitrile-20mmol.L-1 phosphate buffer (pH7.0) (350: 100: 550) .The flow rate was 1.0mL. min-1; detection wavelength 210nm. Results: The linear range of pregabalin was 600.9-1 402.1 mg.L-1, r = 0.999 9. The linear range of the by-products was 2.99- 6.97 mg.L-1, r = 0.999 2. The linear range 0.61 to 1.42 mg.L-1, r = 0.999 9. The lowest detection levels of the three were 2.8, 10.0 and 2.0 ng, respectively, and the pregabalin was well separated from the impurities. Conclusion: This method is simple and fast, high sensitivity, specificity, accurate and reliable.