关于《中国药典》中GC法测定甲醇量的讨论

Discussion on Determination of Methanol Content by GC Method in Pharmacopoeia of China

目的讨论《中国药典》2010年版第三增补本中GC法测定甲醇量检查法中存在的问题。方法分别比较《中国药典》2010年版一部附录ⅨT及第三增补本所载方法进行实验,并对结果进行分析比较。结果《中国药典》2010年版第三增补本所载甲醇量测定方法在实际操作中存在顶空进样平衡时间及分流比设定不合理的问题。结论应延长平衡时间,增大分流比比例,以更好运用于实际检验工作。

OBJECTIVE To discuss the problem of methanol determination in the third supplement of Chinese Pharmacopoeia2010 edition. METHODS The load was applied to the experiment according to methods in Chinese Pharmacopoeia 2010 edition appendix IX T and the third supplement,respectively. The results were analyzed and compared. RESULTS The method of third supplements of the Chinese Pharmacopoeia 2010 edition was unreasonable in determining the amount of methanol contained in setting of the flow ratio and the time of head space sampling.CONCLUSION Equilibration time should be extended and the proportion of split ratio should be increased,so as to be better applied in the actual inspection work.