Development of an HPLC Method for Determination of Related Impurities in Prilocaine Substance
2012 (English)In: Chromatographia, ISSN 0009-5893, E-ISSN 1612-1112, Vol. 75, no 7-8, 329-336 p.Article in journal (Refereed) Published
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)).
Place, publisher, year, edition, pages
2012. Vol. 75, no 7-8, 329-336 p.
LC, Prilocaine impurities, Local anaesthetics, Prilocaine, Hypercarb, Porous graphitized carbon
Biochemistry and Molecular Biology
IdentifiersURN: urn:nbn:se:su:diva-80733DOI: 10.1007/s10337-012-2212-xISI: 000303349400002OAI: oai:DiVA.org:su-80733DiVA: diva2:558702