Mangia A, Silingardi S, Bortesi F, Grisanti G, Di Bitetto M
J Pharm Sci. 1979 May;68(5):652-4. doi: 10.1002/jps.2600680539.
A rapid and accurate quantitative determination of cephacetrile in finished bulk and dosage forms is reported. The high-performance liquid chromatographic method is free of interference by acetyl hydrolysis products and synthesis by-products. The assay can be performed in about 15 min, affording less than 0.7% coefficients of variation within and between days. The chromatographic results are in good agreement with the microbiological assay requested by the "Code of Federal Regulations" for certification of cephacetrile sodium.
本文报道了一种快速、准确地定量测定成品原料药和剂型中头孢乙腈的方法。该高效液相色谱法不受乙酰水解产物和合成副产物的干扰。该测定可在约15分钟内完成,日内和日间变异系数均小于0.7%。色谱结果与《联邦法规法典》要求的用于头孢乙腈钠认证的微生物测定结果高度一致。