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中国药典自1990版收载庆大霉素C组分HPLC检查法以来,不同实验室间的测定误差一直相对较大,为此,9个药品检验所协同开展工作,寻找不同实验室间相对误差较大的原因及有效控制不同实验室间测定误差的方案。研究结果表明,C1组分前后多个不能和C1峰达到基线分离的小杂质峰组分,可使得在不同条件下积分测得的C1组分的含量明显不同,导致各实验室利用规一化法测定庆大霉素C1组分的相对含量结果差异较大。采用英国药典和欧洲药典已收载的相对峰高法测定庆大霉素C组分的含量,可以使我国不同实验室测定误差相对较大这一问题得以较大改善
Since the 1990 edition of the Chinese Pharmacopoeia contains the HPLC method for the determination of gentamicin C by HPLC, the determination error between different laboratories has been relatively large. Therefore, nine drug testing institutes work together to find the relative error among different laboratories The larger reason and effective control of different laboratory error between the program. The results show that the presence of small impurity peak components that can not be separated from the C1 peak before and after the C1 component results in significantly different concentrations of the C1 component under different conditions, resulting in the normalization of laboratory use Determination of the relative content of gentamicin C1 component results vary widely. Using the relative peak height method of the British Pharmacopoeia and the European Pharmacopoeia to measure the content of gentamicin C component can greatly improve the problem that the measurement error of different laboratories in our country is relatively large