Görög S, Balogh G, Gazdag M
Chemical Works of Gedeon Richter Ltd, Budapest, Hungary.
J Pharm Biomed Anal. 1991;9(10-12):829-33. doi: 10.1016/0731-7085(91)80009-x.
The usefulness of the joint application of HPLC and NMR spectroscopy in drug impurity profiling is demonstrated by the following examples: (1) identification of Z and E isomers of 17 alpha-ethynyl-4-oestrene-3 beta, 17-diol-3-acetate-17-(3'-acetoxy-2'-butenoate) in ethynodiol diacetate; (2) identification of the p-tolyl analogue as the impurity of enalapril maleate; (3) identification and quantification of 2'-dehydro-pipecuronium bromide in pipecuronium bromide. The possibilities of utilizing NMR spectroscopy for the identification and quantification of the impurities with and without their isolation are discussed.
高效液相色谱（HPLC）与核磁共振波谱（NMR）联用在药物杂质剖析中的实用性通过以下示例得以证明：（1）鉴定乙炔雌二醇中17α-乙炔基-4-雌烯-3β，17-二醇-3-乙酸酯-17-（3'-乙酰氧基-2'-丁烯酸酯）的Z型和E型异构体；（2）鉴定对甲苯基类似物作为马来酸依那普利的杂质；（3）鉴定并定量泮库溴铵中的2'-脱氢泮库溴铵。本文讨论了利用核磁共振波谱在有或没有分离杂质的情况下进行杂质鉴定和定量的可能性。
