反相高效液相色谱法测定盐酸头孢替安酯含量及有关物质

Determination of content and relevant substances in cefotiam hexetil hydrochloride by RP-HPLC

目的建立反相高效液相色谱法测定盐酸头孢替安酯的含量及有关物质。方法色谱柱为Hypersil C18柱(4.6mm×250mm,5μm),流动相:0.2mol.L-1磷酸二氢钾-乙腈-冰醋酸=72∶28∶1;流速:1mL.min-1,检测波长:254nm,柱温:25℃。结果盐酸头孢替安酯浓度在8～64μg.mL-1时,其峰面积与浓度的线性关系良好(r=0.999 2);平均加样回收率为100.0%,RSD为1.3%(n=6),其有关物质1、2、3的百分含量均低于日本药典15版规定值。结论本法快速、简便、准确、灵敏度高,适用于盐酸头孢替安酯原料药的含量及有关物质的测定。

Objective To establish an RP-HPLC method for the determination of content and relevant substances of cefotiam hexetil hydrochloride.Methods RP-HPLC chromatography was performed on Hypersil C18（4.6 mm×250 mm,5 μm）.The mobile phase consisted of 0.2 mol·L-1 potassium dihydrogen phosphate solution-acetoneitrile-acetic acid（72∶28∶1）.The flow rate was 1.0 mL·min-1,the detection wavelength was 254 nm,and the column temperature was 25 ℃.Results The calibration curve was linear within 8-64 μg·mL-1（r=0.999 2）,the average recovery was 100.0% with RSD of 1.3%（n=6）.The content of relevant substances 1,2 and 3 was less than JP15.Conclusion The method is rapid,simple,accurate,sensitive,and suitable for the determination of content and relevant substances in cefotiam hexetil hydrochloride.