HPLC法测定注射用阿莫西林钠/氟氯西林钠及阿莫西林/氟氯西林钠胶囊的含量及有关物质

Determination of amflucillin for injection and amflucillin capsules by HPLC

目的 建立注射用阿莫西林钠 /氟氯西林钠及阿莫西林 /氟氯西林钠胶囊含量的 HPL C测定方法。方法 使用 C1 8柱 ,以 0 .1mol/ L 磷酸二氢钾 - 0 .0 18mol/ L 十二烷基硫酸钠 -甲醇 -乙腈 (2 75∶ 2 75∶2 0 0∶ 2 5 0 ) (用磷酸调 p H值至 2 .6 )为流动相 ,检测波长为 2 2 5 nm。结果 阿莫西林与氟氯西林的线性范围均为 0 .0 3～ 0 .6 0 mg/ ml,r均为 0 .9999,阿莫西林的平均加样回收率为 99.9% ,RSD为 0 .6 % (n=9) ;氟氯西林的平均加样回收率为 99.9% ,RSD为 1.2 % (n=9)。结论 方法简便、准确、灵敏度高 ,同时对产品中的有关物质能进行准确监控。并通过实验考察了流动相 p H对氟氯西林及其有关物质氯唑西林分离度的影响。

Objective To establish the method for determination of amflucillin for injection and capsules by HPLC. Method A C 18 column was used. The mobile phase was 0.1mol/L KH 2PO 4-0.018mol/L SDS-methanol-acetonitrile (275∶275∶200∶250), using phosphoric acid adjust to pH 2.6. The wavelength of UV detector was 225nm. Results The average recovery of amoxillin was 99.9% (RSD=0.6%, n=9), and the average recovery of Flucloxacillin was 99.9% (RSD=1.2%, n=9). Conclusion The method was convenient and accurate. As the same time, the method can be used to monitor and control the related substances in production. The influence of pH of the mobile phase on resolution factor of flucloxacillin and the related substances cloxacillin was also investigated.