RP-HPLC法测定注射用重组人甲状旁腺素含量

目的: 建立RP-HPLC法测定注射用重组人甲状旁腺素的含量。 方法: 色谱柱为Agilent Zorbax 300SB C₁₈(150 mm×4.6 mm,3.5 μm),流动相为0.2 mol·L^-1硫酸盐缓冲液(pH 2.3)-乙腈(75∶ 25),流速0.8 mL·min^-1,检测波长为214 nm,柱温为40 ℃。 结果: 线性范围:在10~30 μg·mL^-1浓度范围内与峰面积呈良好线性关系(r=0.9997,n=5),最低检出限为20 ng,平均回收率为99.8%(n=9)。 结论: 本方法准确,重复性好,可为注射用重组人甲状旁腺素质量评价提供较为可靠的分析方法。

Objective: To establish an RP-HPLC method for the determination of recombination human parathyroid hormone. Methods: Agilent Zorbax 300SB C₁₈(150 mm×4.6 mm,3.5 μm)was used and the mobile phase was 0.2 mol·L^-1sulfate buffer(pH 2.3)-acetonitrile(75∶ 25)at flow rate of 0.8 mL·min^-1.The UV detection wavelength was 214 nm,and the column temperature was 40 ℃. Result: The calibration curve of recombination human parathyroid hormone was linear in the range of 10-30 μg·mL^-1(r=0.9997,n=5) with the minimum limit of detection was 20 ng.The mean recovery(n=9)was 99.8%. Conclusion: This is an accurate and credible quality control method for recombination Human Parathyroid Hormone.