Development of an HPLC Method for Determination of Related Impurities in Prilocaine Substance
| Autor: | Linda C. Johansson, Magnus B.O. Andersson, Ingrid Granelli, Janina Sroka-Markovic |
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| Rok vydání: | 2012 |
| Předmět: |
Detection limit
Chromatography Chemistry Local anesthetic medicine.drug_class Organic Chemistry Clinical Biochemistry Reversed-phase chromatography Biochemistry High-performance liquid chromatography Prilocaine Analytical Chemistry medicine Hplc method Related impurities Quantitative analysis (chemistry) medicine.drug |
| Zdroj: | Chromatographia. 75:329-336 |
| ISSN: | 1612-1112 0009-5893 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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