| 郑如程,田胜,程正,等.阿莫西林颗粒中有关物质高效液相色谱分析方法的建立[J].安徽医药,2023,27(7):1324-1331. |
| 阿莫西林颗粒中有关物质高效液相色谱分析方法的建立 |
| Establishment of high performance liquid chromatography method for the determination of related substances in amoxicillin granules |
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| DOI：10.3969/j.issn.1009-6469.2023.07.011 |
| 中文关键词: 阿莫西林 药物污染 有关物质 高效液相色谱 梯度洗脱 |
| 英文关键词: Amoxicillin Drug contamination Related substance High performance liquid chromatography (HPLC) Gradient elution |
| 基金项目:安徽省药品监督管理局 2021年度科技创新项目( AHYJ-KJ-202121) |
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| 中文摘要: |
| 目的建立高效液相色谱法测定阿莫西林颗粒中的有关物质。方法 2021年 6月至 2022年 2月，采用高效液相色谱法，色谱柱为 Agilent Zorbax SB-C8(4.6 mm× 250 mm，5 μm)；流动相 A为 0.05 mol/L磷酸缓冲液(取 0.05 mol/L磷酸二氢钾溶液，用 20 %氢氧化钠溶液调节 pH至 5.5)，流动相 B为 0.05 mol/L磷酸缓冲液(取 0.05 mol/L磷酸二氢钾溶液，用 20 %氢氧化钠溶液调节 pH至 4.5)-乙腈(84∶16)；进行梯度洗脱；检测波长为 230 nm；流速为 2.0 mL/min。结果建立了用于分析阿莫西林颗粒中有关物质的高效液相色谱方法，该方法下主峰与各杂质峰间分离良好，各杂质成分在各自线性范围内与峰面积线性关系良好(r≥0.999)，专属性、重复性、精密度、稳定性、耐用性均符合要求。结论该法专属性强、准确度和重复性好，可作为检测阿莫西林颗粒中有关物质的有效方法。 |
| 英文摘要: |
| Objective To establish a high performance liquid chromatography method for the analysis of related substances in amoxicillin granules. Methods The high performance liquid chromatography method was performed on Agilent Zorbax SB-C8 (4.6 mm×250 mm,5 μm) column from June 2021 to February 2022; The mobile phase A was 0.05 mol/L phosphate buffer (0.05 mol/L potassiumdihydrogen phosphate solution, pH adjusted to 5.5 with 20% sodium hydroxide solution), mobile phase B was 0.05 mol/L phosphate buffer (0.05 mol/L potassium dihydrogen phosphate solution, pH adjusted to 4.5 with 20% sodium hydroxide solution) -acetonitrile (84∶ 16); gradient elution; the detected wavelength was 220 nm; the flow rate was 2.0 mL/min.Results A high performance liquid chromatography method was established for the analysis of related substances in amoxicillin granules. The impurities and main componentswere effectively separated, and the impurity components had a good linear relationship with the peak area in their respective linearrange (r≥0.999). The specificity, repeatability, precision, stability and durability all met the requirements.Conclusion This method is suitable for determination of the related substances of Amoxicillin granules. |
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