乌拉地尔原料药中残留溶剂的测定

Determination of residual solvents in urapidil

目的:乌拉地尔原料药中已知残留溶剂的测定及未知残留溶剂的定性定量研究。方法:采用气相色谱法对乌拉地尔原料药中残留溶剂进行测定,并用气质联用法对其中的未知残留溶剂进行确证。结果:乌拉地尔原料药中的未知残留溶剂为苯,并有1家企业超过限度。结论:部分企业生产的乌拉地尔原料药中存在其生产工艺中并未用到的残留溶剂,推测相关药厂未按注册申请的工艺生产或原料药来源存在一定问题。

Objective：To research the residual solvent in urapidiland to identify unknown residual solvent. Meth- od：The residual solvent in urapidil was determined by GC, and the unknown residual solvent was identified by GC - MS. Result： The unknown residual solvent in urapidil is proved to be benzene. Conclusion： The urapidil produced by part of corporation contains the residual solvent benzene, which has not been used in production. It can be specu- late that the substances of interrelated corporation had not been made in the light of its registered technics or the source of substances may had some problems.