HPLC法测定头孢氨苄原料及胶囊中的有关物质

Determination of related substances of cephalexin bulk powder and cephalexin capsules by HPLC

目的建立头孢氨苄原料及胶囊有关物质的HPLC分析方法。方法采用十八烷基硅烷键合硅胶色谱柱;以0.05mol/L磷酸二氢钠溶液(用氢氧化钠试液调节pH值至5.0)为流动相A,甲醇为流动相B,梯度洗脱;检测波长为220nm;流速为1mL/min。结果与中国药典有关物质检测方法比较,本方法具有更强的分析杂质的能力,样品中各成分的分离度及检出灵敏度均满足有关物质限度的测定要求。结论本方法可用于头孢氨苄原料及胶囊有关物质的检查,有助于发现产品中的质量问题,促使产品质量的提高。

Objective To establish a method for the determination of related substances of cephalexin and cephalexin capsules by HPLC. Methods An ODS column was used. The mobile phase consisted of 0.05mol/L sodium dihydrogen phosphate buffer (pH5.0) was used as the mobile phase A and methanol as the mobile phase B. Gradient elution was used. The detection wavelength was 220nm. The flow rate was 1.0mL/min. Results In contrary to the Chinese Pharmacopoeia related substances determination method, this method was more appliable on the separation of the related substances. The damaged degradation products could also be effectively separated from the main peak under this chromatographic condition. The resolution and sensitivity of related substances were acceptable. Conclusion The method is suitable for the determination of the related substances of cephalexin and cephalexin capsules, which helps the discovery of quality problems and promotes the quality of the products.