HPLC法测定匹多莫德口服液中L-噻唑烷-4-羧酸的含量

Determination of 4-thiazolidinecarboxylic acid in pidotimod oral solution by HPLC

目的:建立HPLC法测定匹多莫德口服液中L-噻唑烷-4-羧酸的含量。方法:采用Kromasil 100-5-C18(250 mm×4.6 mm,5μm)色谱柱,以0.01 mol/L磷酸二氢钠溶液(用磷酸调节pH值至2.5)为流动相A,甲醇-异丙醇(2∶1)为流动相B,进行梯度洗脱,流速为1.0 ml/min,柱温为25℃,检测波长为210 nm。结果:L-噻唑烷-4-羧酸在0.54~16.10μg/ml浓度范围内与峰面积呈良好线性关系(r=0.9995),平均回收率为101.73%,RSD为0.52%(n=6),检测限和定量限分别为2.7 ng和10.7 ng。结论:该方法准确、易操作、灵敏度高,可用于匹多莫德口服液的产品质量控制。

Objective:To establish an HPLC method for the determination of 4-thiazolidinecarboxylic acid in pidotimod oral solution. Methods:The chromatographic condition was Kromasil 100-5-C18 column(250 mm× 4.6 mm,5 μm),the mobile phase A was 0.01 mol/L sodium dihydrogen phosphate solution (pH value adjusted to 2.5 by phosphate acid),the mobile phase B was methanol-propanol(2∶1),and the gradient elution was carried out. The flow rate was 1.0 ml/min. The detection wavelength was 210 nm. The column temperature was 25 ℃. Results: The linear range of 4-thiazolidinecarboxylic acid was 0.54~16.10 μg/ml. The average recovery was 101.73%(RSD was 0.52%,n = 6). The limits of detection and the quantification limits were 2.7 and 10.7 ng,respectively. Conclusion: The method is accurate,simple,sensitive,and suitable for the quality control of pidotimod oral solution.