反相HPLC法测定阿奇霉素肠溶片的含量 - 中国药品标准杂志.DOC

加校正因子测定青霉素V钾片有关物质刘琳，李慧刘云（石家庄市食品药品检验，石家庄 050031石家庄 0500） 摘要 目的：建立加校正因子的主成分自身对照法测定青霉素V钾片有关物质的含量。方法：采用XBridge Shield RP18色谱柱（4.6mm×250mm，5μm），磷酸盐缓冲液（pH3.5）-甲醇-水测定杂质4-羟基霉素的校正因子，进行定量分析。结果4-羟基霉素杂质的相对保留时间为0.42，校正因子为1.41；加校正因子的主成分自身对照法与外标法测定的结果无显著性差异。结论：方法准确测定青霉素V钾片中杂质的含量 关键词：；青霉素V钾；4-羟基霉素；有关物质 Determination of Related Substances in Phenoxymethylpenicillin Potassium Tablets Liu Lin1, Li Hui1, Zhang Jing2, Liu Yun1*, Liu zhu1（ Shijiazhuang 050031; 2.Hebei Provincial Institute for Drug Control, Shijiazhuang 050011） Abstract Objective: To establish calibration factor to determine the related substances in Phenoxymethylpenicillin Potassium Tablets. Methods: Chromatographic condition: XBridge Shield RP-18 column (4.6mm?50mm, 5μm), phosphate buffer solution (pH 3.5)-methanol-water as mobile phase with gradient elution, the detection wavelength as 268nm. Determine the correction factor of 4-Hydroxyphenoxymethylpenicillin relative to Phenoxymethylpenicillin, then make the quantitative analysis of the impurity.. Results: The relative retention time and the correction factor of the impurityof 4-Hydroxyphenoxymethylpenicillin were 0.42 and 1.41 respectively. For the content of impurity 4-Hydroxyphenoxymethylpenicillin, there was no significant difference between the results obtained by the method of main component self-control corrected with calibration factor and the external standard method. Conclusion: The simple, efficient and accurate method can be adopted for determination of the specific impurity in Phenoxymethylpenicillin Potassium Tablets. . Key words: correction factor; Phenoxymethylpenicillin Potassium Tablets; 4-Hydroxyphenoxymethylpenicillin ; related substances 青霉素V是继青霉素之后第个天然生产的有临床价值的 β内酰胺类抗生素，是国际上使用极为广泛的一种常用口服青霉素，其抗菌谱与青霉素 Ｇ相似[1]青霉素钾Phenoxymethylpenicillin Potassium）为 《中国药典》 年版的新增品种，年版有收载[]，欧美药典有收载，4-羟基霉素[3]，而且还将4-羟基霉素[4]，《美国药典》则控制杂质苯氧乙酸和4-羟基霉素[5]，而《中国药典》未单独对4-羟基霉素为4-羟基霉素《中国药典》201年版青霉素V钾片[] 采用不加校正因子的主成分自身对照法仅对杂质总量进行了控制，未对其杂质进行控制。我们在承担河北省生产、经营和流通领域“青霉素V钾片”基本药物评价