RP-HPLC法测定盐酸头孢替安酯的含量及有关物质

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和有关物质.方法 采用Inertsil ODS-SP C18色谱柱(150mm×4.6mm,5μm),以0.05mol/L磷酸二氢钾溶液-乙腈-冰醋酸(72:28:1)为含量测定的流动相;检测波长为254nm;柱温为35℃.结果 盐酸头孢替安酯含量测定浓度在0.5μg/mL～500μg/mL范围内线性关系好,线性方程为A=20209C+7646.7,相关系数r=0.9999,定量限为1.0ng,最低检测限为0.5ng.采用所建立的有关物质检查方法,盐酸头孢替安酯主峰能与相邻的杂质峰基线分离.结论 该法简便、准确、灵敏度高,专属性强,可用于盐酸头孢替安酯含量测定和有关物质检查.

Determination of Cefotiam Hexetil Hydrochloride and Related Substances by RP-HPLC

Objective To establish an RP-HPLC method for determination of cefotiam hexetil hydrochloride and related substances. Methods The chromatographic separation of cefotiam hexetil hydrochloride was performed on a Inertsil ODS-SP C 18 column. A mixture of diluted 0.05mol/L potassium dihydrogen phosphate - acetonitrile - glacial acetic acid （72：28：1 ） as mobile phase; The detection was monitored at 254nm, and the column temperature was maintained at 35℃. Results The calibration curve of cefotiam hexetil hydrochloride was linear in range of 0.5~500μg/mL with the correlation coefficient of 0.9999. The limit of quantitation is 1.0ng （S/N=10）, the limit of detection is 0.5ng （S/N=3）. Cefotiam hexetil hydrochloride was completely separated from its related substances. Conclusions The method is simple, rapid, sensitive and specific, and can be used for determination of cefotiam hexetil hydrochloride and related substances.