Fingerprinting of morphine using chromatographic purity profiling and multivariate data analysis
Fingerprinting of morphine using chromatographic purity profiling and multivariate data analysis
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DOI：
10.1016/j.jpba.2015.02.016
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发表时间：
2015-05-10
影响因子：
3.4
通讯作者：
Dimitrovska, Aneta
中科院分区：
文献类型：
--
作者：
Acevska, Jelena;Stefkov, Gjoshe;Dimitrovska, Aneta
色谱纯度分析（CPP）是一组分析和化学计量学应用的通用名称，用于检测、鉴定和定量测定活性药物成分（API）和成品剂型（FDF）中的有关物质和其他杂质。CPP用于指纹识别和区分样品，因此代表了现代药物分析的核心活动。全世界对吗啡及其同类物的需求量巨大，完全依赖于天然阿片剂的供应。本研究的目的是开发一种新的方法，使识别吗啡的来源，从而揭示伪造的substance.The特征和重现性的特点，杂质谱的28个样品的吗啡（6吗啡硫酸盐，9吗啡盐酸盐和13吗啡碱）被捕获的一种新的LC/MS方法的杂质谱。杂质谱包括相关欧洲药典中规定的有关物质。专论，以及其他吗啡烷类杂质，包括天然存在的共提取生物碱。不同的模式识别技术（无监督和有监督）本研究结果为吗啡的色谱纯度谱与多元数据分析相结合进行指纹图谱分析提供了可能性样品(C)2015爱思唯尔B. V.保留所有权利。
Chromatographic purity profiling (CPP) is the common name of a group of analytical and chemometric applications for detection, identification and quantitative determination of related substances and other impurities in active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). CPP is used for fingerprinting and discriminating between samples, thus representing a core activity in modern drug analysis. The worldwide demand for morphine and its congeners is tremendous and depends entirely on the supply of natural opiates. The aim of this research was to develop a methodology that enables identification of a source of morphine, thus revealing falsification of the substance.The characteristic and reproducible features of impurity profiles for 28 samples of morphine (6 morphine sulfate, 9 morphine hydrochloride and 13 morphine base) were captured by a new LC/MS method for impurity profiling of morphine. The impurity profile encompasses the related substances specified in relevant Ph.Eur. monographs, as well as the other morphinane like impurities, including the naturally occurring co-extracted alkaloids.Different pattern recognition techniques (unsupervised and supervised) were used to reveal the differentiation features of the morphine fingerprints for classification and authentication purposes.The results described in this research open the possibility of using the chromatographic purity profile combined with multivariate data analysis for fingerprinting of morphine samples. (C) 2015 Elsevier B.V. All rights reserved.