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醋酸曲普瑞林注射液有关物质测定方法研究

Chinese Journal of New Drugs(2022)

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Abstract
目的:评价醋酸曲普瑞林注射液现行质量标准中有关物质测定方法,并建立分离效果更好、杂质检出能力更强的HPLC方法.方法:通过改变流动相类型、比例、洗脱梯度、柱温等色谱条件,优化有关物质方法,并采用稳定性样品及多批次上市产品评价新的检测方法.结果:曲普瑞林峰与相邻杂质峰分离良好;专属性、耐用性、精密度良好;醋酸曲普瑞林在4.0~200μg·mL-1浓度范围内呈良好的线性关系(R2=0.9999);检出限和定量限分别为0.2和0.4 ng.结论:该方法适用于醋酸曲普瑞林注射液有关物质的测定,且分离效果更好.
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