| 刘琳,李慧,张菁,刘云,刘珠.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[J].中国药品标准,2017,18(1):29-33 |
| 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 |
| The Method of Main Component Self-Control Corrected with Calibration Factor Was Used for Determination of Related Substances in Phenoxymethylpenicillin Potassium Tablets |
| 投稿时间：2016-08-29 修订日期：2017-01-06 |
| DOI： |
| 中文关键词: 校正因子 青霉素V钾片 4-羟基苯氧甲基青霉素 有关物质 |
| 英文关键词: correction factor Phenoxymethylpenicillin Potassium Tablets |
| 基金项目: |
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| 摘要点击次数: 1052 |
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| 中文摘要: |
| 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（4.6mm×250mm，5μm），以磷酸盐缓冲液（pH3.5）-甲醇-水为流动相，梯度洗脱；检测波长268nm；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。 |
| 英文摘要: |
| 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 (4.6mm×250mm, 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. . |
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