Development of an HPLC Method for Determination of Related Impurities in Prilocaine Substance

被引：4

作者：

Sroka-Markovic, Janina ^{[2
]}

Johansson, Linda ^{[2
]}

Andersson, Magnus B. O. ^{[2
]}

Granelli, Ingrid ^{[1
]}

机构：

[1] Stockholm Univ, Dept Analyt Chem, S-10691 Stockholm, Sweden

[2] AstraZeneca, Analyt Dev, S-15185 Sodertalje, Sweden

来源：

CHROMATOGRAPHIA | 2012年 / 75卷 / 7-8期

关键词：

LC; Prilocaine impurities; Local anaesthetics; Prilocaine; Hypercarb; Porous graphitized carbon; POROUS GRAPHITIC CARBON; PERFORMANCE LIQUID-CHROMATOGRAPHY; PRINCIPAL COMPONENT ANALYSIS; STATIONARY PHASES; COLUMNS; CLASSIFICATION; SEPARATION; RETENTION; ISOMERS; ION;

D O I：

10.1007/s10337-012-2212-x

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Development of a reversed phase high performance liquid chromatographic method for determination of six related impurities in prilocaine substance is reported. The test of related impurities in European Pharmacopoeia (Ph. Eur.) cannot meet the demands with the chromatographic parameters given, therefore different types of chromatographic systems and eight columns have been evaluated in the present study. A new method with a Hypercarb column was developed and validated. This method fulfils the demands in the Ph. Eur., and the validation shows that the method is selective, reproducible, linear, accurate and robust with sufficient limits of detection (0.001-0.004% of 2.5 mg prilocaine mL(-1)) and quantification (0.002-0.009% of 2.5 mg prilocaine mL(-1)).

引用

页码：329 / 336

页数：8

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