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目的建立测定人血清中那格列奈浓度的高效液相色谱法。方法血清中加入内标后经固相萃取,色谱柱为AlltechApollo C_(18)(4.6×250mm,5μm)。流动相:乙腈-水相(0.1%三乙胺,H_3PO_4调pH=2.5)=60:40(V/V),流速1.0ml·min~(-1),检测波长为2100nm。结果本方法线性检查范围为125～20000ng·ml~(-1),最低检测浓度为125ng·ml~(-1),r=0.9968,定量限为125ng·ml~(-1),相对回收率为101.60%～105.42%,日内、日间精密度的RSD均小于10%。结论本方法灵敏度高、操作简便,可用于人血清中那格列奈浓度的测定及临床药代动力学研究。
Objective To establish a HPLC method for the determination of nateglinide in human serum. Methods After the internal standard was added into the serum, all the samples were separated by solid phase extraction. The column was Alltech Apollo C_ (18) (4.6 × 250 mm, 5 μm). The mobile phase consisted of acetonitrile - water (0.1% triethylamine and H_3PO_4 adjusted to pH = 2.5) = 60:40 (V / V) and the flow rate was 1.0 ml · min -1 .The detection wavelength was 2100 nm. Results The linear range of this method was 125 ~ 20000 ng · ml ~ (-1), the lowest detection limit was 125 ng · ml ~ (-1), r = 0.9968, and the limit of quantification was 125 ng · ml ~ (-1) Was 101.60% ~ 105.42%. The RSD of intra-day and inter-day precision was less than 10%. Conclusion The method is sensitive and easy to operate. It can be used to determine the concentration of nateglinide in human serum and study its clinical pharmacokinetics.