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目的建立HPLC测定L-肌肽原料药的含量并进行有关物质检查。方法采用KromasilNH2色谱柱(4.6mm×200mm,5μm),流动相为乙腈-40mmol·L-1磷酸氢二钾溶液(44∶56,磷酸调pH6.3),流速1.0mL·min-1,检测波长为210nm,柱温35℃。结果L-肌肽在9.93～99.3mg·L-1内线性关系良好(r=0.9998),平均回收率为100.5%(RSD=1.0%),检测限为1ng(S/N=3)。L-肌肽与有关物质分离良好。结论该方法操作简便、重复性好、专属性强,可用作L-肌肽原料药的含量测定和有关物质检查。
Objective To establish an HPLC method for the determination of L-carnosine and its related substances. Methods Kromasil NH2 column (4.6 mm × 200 mm, 5 μm) was used. The mobile phase was acetonitrile-40 mmol·L-1 dipotassium hydrogen phosphate solution (44:56, phosphoric acid, pH6.3) at a flow rate of 1.0 mL · min- Wavelength of 210nm, column temperature 35 ℃. Results The linear range of L-carnosine was 9.93 ~ 99.3 mg · L-1 (r = 0.9998). The average recovery was 100.5% (RSD = 1.0%) and the limit of detection was 1 ng (S / N = 3). L-carnosine and related substances isolated. Conclusion The method is simple, reproducible and specific. It can be used as the content determination of L-carnosine and its related substances.