离子抑制色谱法测定醋酸曲普瑞林注射液中醋酸的含量

目的:利用离子抑制色谱法测定醋酸曲普瑞林注射液中醋酸的含量。方法:采用Rezex ROA-Organic Acid H⁺(7.8 mm×300 mm)色谱柱,以0.002 5 mol·L^-1硫酸为流动相,流速0.5 mL·min^-1,柱温 45 ℃,检测波长210 nm,醋酸的含量按外标法以峰面积计算。结果:醋酸的检测限为78.89 ng·mL^-1,定量限为197.2 ng·mL^-1;醋酸质量浓度在0.394 4~78.89 μg·mL^-1范围内线性关系良好(r=0.999 9);平均回收率(n=9)为98.69%,RSD为0.51%;3批醋酸曲普瑞林注射液中醋酸含量分别为23.99、22.38和 22.96 μg·mL^-1。结论:本方法环保、简便,准确度及精密度良好,适用于醋酸曲普瑞林注射液中醋酸的定量分析。

Objective:To establish an ion-exclusion chromatography(IEC)method to determine the content of acetic acid in triptorelin acetate injection.Methods:Rezex ROA-Organic Acid H⁺(7.8 mm×300 mm)column was applied for the study.The mobile phase consisted of 0.002 5 mol·L^-1 sulfuric acid at a flow rate of 0.5 mL·min^-1.The column temperature was 45℃,and the detection wavelength was 210 nm.The assay was quantitatively completed by external standard method.Results:The LOD of acetic acid was 78.89 ng·mL^-1,and the LOQ was 197.2 ng·mL^-1.The linearly dependent coefficient was 0.999 9 when the content of acetic acid ranged from 0.394 4 μg·mL^-1 to 78.89 μg·mL^-1.The average recovery(n=9)was 98.69% with a RSD of 0.51%.The content of acetic acid in 3 batches of triptorelin acetate injection were 23.99 μg·mL^-1,22.38 μg·mL^-1, and 22.96 μg·mL^-1,respectively.Conclusion:The established method is environmental-friendly,concise,accurate and precise,which can be applied to the content determination of acetic acid in triptorelin acetate injection.