摘要
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(R^(2)=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。
Objective:To evaluate the determination methods of related substances in the current quality standards for triptorelin acetate injection,and to establish an HPLC method with better separation effect and stronger impurity detection.Methods:By changing the chromatographic conditions such as mobile phase type,ratio,elution gradient,and column temperature,the determination method of related substances was optimized.The stable samples and multiple batches of marketed products were used to evaluate the newly developed methods.Results:Triptorelin peak was well separated from peaks of adjacent impurity with good specificity,durability and precision.A good linear relationship was shown for tiptorelin acetate in the concentration range of 4.0~200μg·mL^(-1)(R^(2)=0.9999).The limit of detection(LOD)and limit of quantification(LOQ)were 0.2 and 0.4 ng,respectively.Conclusion:This method is suitable for the determination of related substances of triptorelin acetate injection with a better separation then previous methods.
作者
孙悦
陈志禹
张伟
张慧
梁成罡
SUN Yue;CHEN Zhi-yu;ZHANG Wei;ZHANG Hui;LIANG Cheng-gang(National Institutes for Food and Drug Control,Beijing 102600,China;Ningbo Institute for Drug Control,Ningbo 315040,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第3期269-276,共8页
Chinese Journal of New Drugs
