铋甲西林片的高效液相色谱分析研究

Study on the determination of metronidazole and amoxicillin in Bijiaxilin tablet by HPLC

目的 建立铋甲西林片中甲硝唑和阿莫西林的含量测定方法 ,为制剂的质量控制提供有效的分析手段。方法 采用反相高效液相色谱法 ,色谱柱为Shim PackCLC ODS(6 .0mm× 15 0mm)不锈钢柱 ,以pH6 .5 ,0 .0 2mol·L-1磷酸盐缓冲液 乙腈 (90∶10 )为流动相 ,流速 1mL·min-1,检测波长 2 72nm ,进样量 10 μL。考察了不同流动相下两主药的色谱行为、供试品溶媒对甲硝唑和阿莫西林稳定性的影响情况。结果 甲硝唑和阿莫西林可完全分离 ,片剂辅料、其它主药成分、有关杂质和降解产物对两主药无干扰 ,方法用于铋甲西林片中甲硝唑和阿莫西林的同时测定 ,回收率分别为 99.88%和 99.96 % ,RSD <1.7%。结论 方法专属性强 ,操作方便 ,结果准确 ,重现性好。

OBJECTIVE In order to control the quality of Bijiaxilin tablet, a method for the determination of metronidazole and amoxicillin was developed.METHOD A HPLC procedure was established.A 6.0 mm×150 mm Shim Pack CLC ODS column with a mobile phase consisting of pH6.5,0.02 mol·L -1 phosphate buffer acetonitrile(90∶10) was used.A 10 μL portion of the sample solution was chromatographed and detected at 272 nm.The effects of the types of the mobile phase on the retention behaviour of metronidazole,amoxicillin and the other components in the samples were investigated.The effect of the solvent used for sample preparation on the stability of metronidazole and amoxicillin was also studied.RESULTS Metronidazole,amoxicillin and the other components in the samples were separated completely.The recoveries were 99.88% for metronidazole and 99.96% for amoxicillin with RSD less than 1.7%.CONCLUSION The proposed method is selective,simple,accurate and precise.