L-缬氨酸甲酯盐酸盐中杂质与缬沙坦中有关物质的关系  

Relationship between the Impurity in L-Valine Methyl Ester Hydrochloride and the Related Substance in Valsartan

作　　者：殷静[1] 郭拥政 陈永晨[1] 蒋玲敏[1] 邹江[1] 

机构地区：[1]北京赛科药业有限责任公司研发部,北京100021 [2]浙江新赛科药业有限公司,浙江上虞312369

出　　处：《中国医药工业杂志》2010年第11期849-851,共3页Chinese Journal of Pharmaceuticals

摘　　要：通过研究起始物料L-缬氨酸甲酯盐酸盐(2)中的杂质L-异亮氨酸甲酯盐酸盐(4)与成品缬沙坦(1)中有关物质E(3)之间的关系,以控制1的质量。采用气相色谱法测定杂质4,高效液相色谱法测定1中的3。通过多批次、含有不同比例4的2进行合成反应,考察1中3的比例变化,结果显示,若4比例不超过0.15%,则1中3含量不超过0.10%。The relationship between L-isoleucine methyl ester hydrochloride（4） in L-valine methyl ester hydrochloride（2） and related substance E（3） in valsartan（1） was studied for quality control of 1.Compound 4 and 3 in 1 were determined by GC and HPLC.Different batches of 2 containing different proportion of 4 were used to give 1 and the change of 3 in 1 was investigated to find the appropriate proportion of 4.The result showed that there was no more than 0.10% 3 in 1 with no more than 0.15% 4 in 2.

关 键 词：缬沙坦 L-缬氨酸甲酯 L-异亮氨酸甲酯 有关物质 

分 类 号：R917[医药卫生—药物分析学]