高效液相色谱法测定特立帕肽含量的方法研究

Study on HPLC determination of teriparatide

目的：建立HPLC测定特立帕肽含量的方法。方法：采用Kromasil C18（4.6 mm×250 mm,5μm）色谱柱,流动相为0.05mol·L^-1氯化钾溶液（磷酸调节至pH 4.5）-乙腈（75∶25）,流速1.0 mL·min^-1;检测波长210 nm;柱温为室温;进样量20μL。结果：特立帕肽浓度在0.05-0.84 mg·mL^-1范围内具有良好的线性关系,r=0.9999。结论：本方法简便、准确,灵敏度高,重现性好,可用于测定特立帕肽的含量。

Objective：To develop an effective method for determination of teriparatide by HPLC.Methods：Teriparatide was determinated on HPLC instrument fixed with a Kromasil C18（4.6 mm×250 mm,5μm） column.The mobile phase was water with 0.05 mol·L^-1 KCl（adjusted to pH 4.5 with phosphoric acid）-acetonitrile（75∶25） at the flow rate of 1.0 mL· min^-1;The detector was set at 210 nm;Column temperature was room temperature,and the injection volume was 20 μL.Results：The calibration curve was linear（r=0.9999） within the range of 0.05-0.84 mg·mL^-1 for teriparatide.Conclusion：The method is simple,accurate,good sensitive,reproducible and is suitable for the determination of teriparatide