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 Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Schilling K,Amstalden MC,Meinel L,Holzgrabe Udoi
10.1016/j.jpba.2016.08.035subject
Has Abstractpub_date
2016-11-30 00:00:00pages
202-207eissn
0731-7085issn
1873-264Xpii
S0731-7085(16)30480-0journal_volume
131pub_type
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