摘要
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。
A HPLC method was carried out for determination of Gentamicin C components in Chinese Pharmacopoeia since 1990. However, the analytical variability in different labs are diverse. Therefore, 9 institutes for drug control worked together to try to find out the reasons of variability and to come up with an effective strategy to control the variability. Results show that it is some small impurities peaks which were difficult to be separated from the C 1 component resulting in a significant difference of the C 1 content under different integrated condition. It may be the reason that leads to the analytical variability in determination of the C 1 component among different labs using normalization method. Using a relative peak height method for determination of the C components developed in British Pharmacopoeia and Europe Pharmacopoeia, the above problem can be improved distinctly.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1999年第4期284-287,共4页
Chinese Journal of Antibiotics
