反相高效液相色谱法测定醋酸去氨加压素片及注射液含量

目的: 建立反相高效液相色谱法测定醋酸去氨加压素片及醋酸去氨加压素注射液含量。 方法: 选用Kromasil C₁₈柱(4.6 mm×250 mm,5 μm);流动相:乙腈-水(20∶ 80)(含0.067 mol·L^-1磷酸二氢钾,0.067 mol·L^-1磷酸氢二钠,调节磷酸盐比例使pH为7.0);流速:1.0 mL·min^-1;紫外检测波长:220 nm;进样量:片剂20 μL,注射剂100 μL;柱温:室温。 结果: 方法的线性范围为0.008~2 μg,r=0.9999,最低检测限为4.0 ng;片剂的平均回收率为101.2%,RSD为0.78%(n=9),注射液的平均回收率为100.8%,RSD为1.1%(n=9)。 结论: 本方法快速灵敏,结果准确可靠,可用于醋酸去氨加压素片及醋酸去氨加压素注射液含量的测定。

Objective: To establish HPLC method for the determination of desmopressin acetate tablets and desmopressin acetate injection. Method: Kromasil C₁₈ column(4.6 mm×250 mm,5 μm),with mobile phase consisted of acetonitrile-water(20:80)containing 0.067 mol·L^-1potassium dihydrogen phosphate and 0.067 mol·L^-1sodium hydrogen phosphate,adjust to pH 7.0 by choosing appropriate proportion;the flow rate was 1.0 mL·min^-1;detection wavelength at 220 nm,the injection volume was 20 μL for tablets,and 100 μL for injection,and the column temperature was room tempreture. Results: The linear range of the method was 0.008-2 μg(r=0.9999),the limit of detection was 4.0 ng,the average recovery was 101.2%,with RSD of 0.78%(n=9)for tablets and 100.8%,with RSD of 1.1%(n=9)for injection. Conclusion: The method is rapid,sensitive and accurate and can be used for the determination of desompressin acetate tablets and desompressin acetate injection.