摘要
建立了高效液相色谱法测定盐酸头孢他美酯原料药、片剂、胶囊、干混悬剂及分散片中的有关物质。使用Capcell PAK C18色谱柱，以5mmol／L四丁基氢氧化铵溶液（用磷酸调至pH4．5）为流动相A，乙腈为流动相B，梯度洗脱，检测波长232nm。结果显示盐酸头孢他美酯与有关物质分离完全。头孢他美酯在5～100μg／ml范围内线性关系良好，回收率为99．8％，RSD为1．2％。
An HPLC method was established for the determination of the related substances in cefetamet pivoxil hydrochloride and its tablets, capsules, dry suspensions and dispersible tablets. A Capcell PAK C18 column was used, with the mobile phase A of 5 mmol/L tetrabutylammonium hydroxide solution （adjusted to pH 4.5 with phosphoric acid） and the mobile phase B of acetonitrile by gradient elution, at the detection wavelength of 232 nm. Cefetamet pivoxil hydrochloride and its related substances were separated well. It was linear for cefetamet pivoxil hydrochloride in the range of 5-100 μg/ml, and its average recovery was 99.8 %, with RSD of 1.2 %.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2016年第7期918-923,共6页
Chinese Journal of Pharmaceuticals
