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机构地区:[1]潍坊市食品药品检验检测中心,潍坊261061
出 处:《中国药品标准》2015年第2期130-132,共3页Drug Standards of China
摘 要:目的:改进琥乙红霉素片的含量测定方法。方法:采用高效液相色谱法,色谱柱为 ZORBAX SB-C18,以0.067 mol· L-1磷酸二氢铵溶液(三乙胺含量0.3%,调pH值至7.5)-乙腈(50∶50)为流动相,检测波长208 nm,用外标法计算琥乙红霉素片含量。结果:含量在0.53~5.27 mg· mL-1( R2=0.9994)浓度范围内呈良好的线性关系,平均回收率为98.18%( RSD=0.96%)。结论:该方法简便、准确,重复性好,灵敏度高,适用于琥乙红霉素片含量的测定。Objective:To improve the method for determining Erythromycin Ethylsuccinate Tablets .Method:HPLC method was per-formed on a C18 column with the mobile phase of 0.067 mol· L-1 ammonium dihydrogen phosphate (0.3%TEAadjusted to pH 7.5)-acetonitrile (50∶50) and detection wavelength was set at 208nm.The contents were determined by external standard .Results: The calibration curve was linear in the range of 0.53-5.27 mg· mL-1 ( R2 =0.999 4 ) , the average recovery was 98.18% with RSD of 0.96%.Conclusion:The method is simple , rapid and accurate .It can be used for the determination of Erythromycin Ethylsuccinate Tablets.
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