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Journal of Pharmaceutical and Biomedical Analysis

23 (2000) 757 – 761


Short communication

Determination of piracetam and its impurities by TLC

J.F. Ovalles a,1, J.N.A. Tettey a, J.H. McB Miller b, G.G. Skellern a,*
Department of Pharmaceutical Sciences, Strathclyde Institute for Biomedical Sciences, Uni6ersity of Strathclyde,
27 Taylor Street, Glasgow G4 0NR, UK
European Department for the Quality of Medicines, European Pharmacopoeia, Strasbourg, France

Received 8 March 1999; received in revised form 8 May 2000; accepted 8 May 2000

Keywords: Piracetam; Impurities; TLC-densitometry; TLC

1. Introduction published. This paper describes the development

of a simple and reproducible TLC method for the
Piracetam (2-oxo-1-pyrollidine acetamine (I), separation and detection of related substances in
Fig. 1) which is the prototype of nootropic drugs, piracetam. A range of detection reagents were
is used mostly for the improvement of learning examined for their suitability in providing optimal
and memory, and in the treatment of myclonus detection, simultaneously, for all the compounds
[1,2]. Samples of piracetam may contain some examined.
structurally related impurities (Fig. 1) derived
from the manufacturing process (2-oxo-pyrol-
lidine (II), 2-oxo-1-pyrollidine methyl acetate (IV) 2. Experimental
and 2-oxo-1-pyrollidine ethyl acetate (V)) or by
degradation (2-oxo-1-pyrollidine acetic acid (III)). 2.1. Reference substances
Various analytical methods have been reported
for the analysis of piracetam [3 – 15]. However, to Piracetam (I) and the related substances (II–V)
date no chromatographic methods for the simul- were supplied by Union Chimique-chemische,
taneous separation of piracetam from all its Belgium.
known structurally related impurities have been
2.2. Chemicals and reagents
* Corresponding author. Tel.: + 44-141-5482263; fax: +44-
Ethyl acetate, ethanol, methanol, acetonitrile
E-mail address: g.g.skellern@strath.ac.uk (G.G. Skellern).
Present address: Universidad de los Andes, Facultad de and chloroform, all HPLC grade and glacial
Farmacia, Departmento de Análysis y Control, Mérida estado acetic acid (GPR grade) were obtained from
Mérida, Venezuela. Rathburn Chemicals, Scotland. Pentyl acetate

0731-7085/00/$ - see front matter © 2000 Elsevier Science B.V. All rights reserved.
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