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机构地区:[1]石家庄市食品药品检验中心,石家庄050031 [2]河北省药品检验研究院,石家庄050011
出 处:《中国药品标准》2017年第1期29-33,共5页Drug Standards of China
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 RP-18色谱柱(4.6 mm×250 mm,5μm),以磷酸盐缓冲液(pH 3.5)-甲醇-水为流动相,梯度洗脱;检测波长268 nm;测定特定杂质4-羟基苯氧甲基青霉素相对于青霉素V的校正因子,并进行定量分析。结果:4-羟基苯氧甲基青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:该方法简便快速,可准确测定青霉素V钾片中特定杂质的含量。Objective: To establish the method of main component self-control corrected with calibration factor to determine the related substances in Phenoxymethylpenicillin Potassium Tablets. Methods: Chromatographic condition: XBridge Shield RP-18 column (4. 6 mm x 250 ram, 5 μm), phosphate buffer solution (pH 3.5 )-methanol-water as mobile phase with gradient elution, the detection wave- length as 268 nm. Determine the correction factor of 4-Hydroxyphenoxymethylpenieillin relative to Phenoxymethylpenicillin, then make the quantitative analysis of the impurity. Results: The relative retention time and the correction factor of the impurityof 4-Hydroxyphe- noxymethylpenicillin were 0. 42 and 1.41 respectively. For the content of impurity 4-Hydroxyphenoxymethylpenicillin, there was no sig- nificant 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 im- purity in Phenoxymethylpenicillin Potassium Tablets.
关 键 词:校正因子 青霉素V钾片 4-羟基苯氧甲基青霉素 有关物质
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