注射用头孢曲松钠中抗氧剂测定方法的建立

An HPLC method for determination of butylated hydroxytoluene in ceftriaxone sodium for injection

目的建立测定注射用头孢曲松钠中抗氧剂2,6-叔丁基-4-甲基-苯酚(BHT)的HPLC方法。方法Alltima C18色谱柱(4.6mm×250mm,5μm),以乙腈∶水(77∶23)为流动相,检测波长208nm,流速1.0ml/min,柱温为室温。结果色谱图中抗氧剂BHT与其他成分的分离度及其检出灵敏度完全满足检测要求,最小检出量为1.3ng。结论本法简便、专属、能有效控制产品的质量。

Objective To develop an HPLC method for determination of butylated hydroxytoluene （BHT） in ceftriaxone sodium for injection. Methods BHT and other related substances in ceftriaxone sodium were separated by a mobile phase consisted of acetonitrile ： water （77 ： 23, V/V） at a flow rate of 1.0ml/min on an Alltima C18 column and detected at 208 nm. Results The resolution and sensitivity of BHT were acceptable. The detection limit was 1.3 ng. Conclusions This method simple and specific to be used for the quality control of ceftriaxone soeium for injection.