HPLC测定盐酸头孢吡肟的含量和有关物质

 目的建立盐酸头孢吡肟有关物质及含量的分析方法。方法使用C₁₈柱(4.6mm×250mm,5μm),检测波长为257nm。测定有关物质时,为线性梯度洗脱,流动相A为0.005mol·L^-1磷酸二氢铵-乙腈(93:7),流动相B为0.005mol·L^-1磷酸二氢铵-乙腈(70:30);测定含量时,为等度洗脱,流动相为0.005mol·L^-1磷酸二氢铵-乙腈(93:7)。结果盐酸头孢吡肟与其中间体、降解产物及E异构体分离良好。结论方法简便、专属,可用于盐酸头孢吡肟含量及有关物质的测定。

Determination of cefepime hydrochloride and its related substances by HPLC

OBJECTIVE To establish a HPLC method for the determination of cefepime hydrochloride and its related substances. METHODS The chromatographic separation of the related substances was performed on a C₁₈ column(4.6 mm×250 mm,5μm) with a linear gradient elution, 0.005 mol·L^-1ammonium phosphate monobasic-acetonitrile(93:7) as mobile phase A,0.005 mol·L^-1 ammonium phosphate monobasic-acetonitrile(70:30) as mobile phase B. The UV detection wavelength was 257 nm. The chromatographic separation for determing cefepime hydrochloride was performed on a C₁₈ column(4.6 mm×250 mm,5μm).The mobile phase consisted of 0.005 mol· L^-1 ammonium phosphate monobasic-acetonitrile(93:7). The UV detection wavelength was 257 nm.RESULTS The method was proved to be selective for the separation of cefepime hydrochloride, its degradation products and E-isomer. CONCLUSION The method is simple, selective and suitable for the determination of cefepime hydrochloride and related substances.