摘要
目的建立测定盐酸头孢他美酯颗粒中有关物质的方法。方法采用高效液相色谱法（HPLC），C18色谱柱，以乙腈-甲醇-水-磷酸盐缓冲液（360：95：500：45）为流动相，DAD检测器，检测波长263nm。结果头孢他美酯峰与相对保留时间约为0．9和1．1处杂质峰的分离度均大于2．0，专属性良好，强制降解试验中各降解杂质与主峰分离良好，头孢他美酯在2．789-55．78μg／mL浓度范围内与峰面积线性关系良好，相关系数r=0．9996，定量限和检测限分别为0．67μg／mL和0．22μg／mL。结论该方法专属性好，灵敏度高，可作为测定盐酸头孢他美酯颗粒有关物质的方法。
Objective To establish an accurate method to determine the related substance in Cefetamet Pivoxil Hydrochloride Granules. Methods HPLC and a C18 column were used for the separation. The mobile phase was acetonitrile-methanol- water-phosphate buffered solution（360：95：500：45）. The detection wavelength was set at 263 nm. Results The resolutions among the peaks of cefetamet pivoxil and impurities with relative retention time of 0.9 and 1.1 were more than 2.0. In the forced degrading tests, the main peaks separated well with peaks of degraded impurities. The linearity of cefetamet pivoxil （calculated as cefetamet） was good in the range of 1.989-39.78 μg/mL, r=0.9996. The limit of quantification and detection were 0.48 and 0.16 μg/mL, respectively. Conclusion The method is sensitive and of good specificity for determination of the related substances of Cefetamet Pivoxil Hydrochloride Granules.
出处
《食品与药品》
CAS
2014年第4期270-272,共3页
Food and Drug
