Impurity profiling of l-asparagine monohydrate by ion pair chromatography applying low wavelength UV detection.

Abstract:

:l-asparagine is a non-essential amino acid being used for a variety of pharmaceutical applications. The compound may be produced following synthetic or fermentative pathways leading to the formation of distinct impurities such as organic acids, other amino acids, dipeptides, or cyclic amino acid derivatives. Analysis of the respective analytes is challenging due to the lack of a chromophore, thus the monograph of the European Pharmacopoeia describes a thin layer chromatographic test for detection of other amino acids. Thus, a sensitive and robust liquid chromatographic method was developed and validated applying detection at 210nm for determining the related substances. Separation and quantification of the analytes was achieved on a reversed phase C18 column using a mobile phase composed of a mixture of a phosphate buffer, sodium octanesulfonate, and acetonitrile in an isocratic elution mode. In contrast to the currently used thin layer chromatographic test, the method is capable of separating and quantitatively assessing expected ninhydrin-positive and -negative impurities from synthetic and enzymatic production pathways.

journal_name

J Pharm Biomed Anal

authors

Schilling K,Amstalden MC,Meinel L,Holzgrabe U

doi

10.1016/j.jpba.2016.08.035

subject

Has Abstract

pub_date

2016-11-30 00:00:00

pages

202-207

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(16)30480-0

journal_volume

131

pub_type

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