HPLC测定米格列奈钙原料药的含量及有关物质

目的用HPLC法测定米格列奈钙原料药的含量及有关物质，为米格列奈钙原料药的含量和有关物质测定提供检测方法，制定指控标准。方法Alhech C18色谱柱（250mm×4．6mm，5μm），采用乙腈-水（55：45）用稀磷酸调pH=2．5作为流动相，检测波长：210nm，流速：0．8ml·min^-1。结果主峰能与相邻杂质峰较好分离，浓度在3．38—33．8mg·L^-1的范围内，米格列奈钙的峰面积和浓度有良好的线性关系，r=0．9999。结论该方法简便、专属性好、灵敏度高，可用于米格列奈钙的含量及有关物质测定的需要。

HPLC determination of mitiglinide calcinm and its related substances

Aim To establish an HPLC method for the determination of mitiglinide calcium and its related substances.Methods Alltech C 18column(250 mm ×4.6 mm,5 μm),was adopted,with a mobile phase of acetonitrile H 2O(55:45)(pH adjusted to 2.5 with phosphoric acid).The flow rate was 0.8 ml·min-1,and the detected wavelength was 210 nm.Results Mitiglinide calcium was completely separated from impurities.The calibrated linear curve was from 3.38 mg·L-1 to 33.8 mg·L-1(r=0.9999).Conclusion The method was accurate and reliable.It is applicable for the quality control of mitiglinide and its related substances.