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Control of Impurities in L-aspartic Acid and L-alanine by High-performance Liquid Chromatography Coupled with a Corona Charged Aerosol Detector by Ulrike Holzgrabe; Cees-Jan Nap; Stefan Almeling is a Chemistry article available to read on EtoBox.

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HPLC) Charged aerosol detector (CAD) Evaporative light scattering detector (ELSD) a b s t r a c t In this study a reversed phase ion-pair high-performance liquid chromatography (HPLC) method using charged aerosol detection (CAD) was developed and fully validated for the pharmaceutical quality control of l-aspartic acid (Asp). With a slight modification, the method also allows the evaluation of related substances in l-alanine (Ala). The method enables simultaneous control of related amino acids and of possibly occurring organic acids contaminants. A minimum limit of quantification of 0.03% could be achieved for all occurring related substances. Moreover, the detector sensitivity of the CAD was compared with an evaporative light scattering detector (ELSD). Depending on the analyte the CAD was found to be 3.6-42 times more sensitive than the ELSD. The HPLC method was applied to the purity testing of 8 samples of pharmaceutical grade and reagent grade Asp and of 12 samples of Ala supplied by various manufacturers. Both substances were found to be of high purity (greater than 99.8% for Asp and greater than 99.9% for Ala). Malic acid and Ala were the major impurities in Asp. Asp and glut

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Author

Ulrike Holzgrabe; Cees-Jan Nap; Stefan Almeling

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 1873-3778)

Published

2010

Language

EN

Field

Chemistry (Physical Sciences)