Validated HPLC determination of 2-[(dimethylamino)methyl]cyclohexanone, an impurity in tramadol, using a precolumn derivatisation reaction with 2,4-dinitrophenylhydrazine.

Abstract:

:A new method for the determination of 2-[(dimethylamino)methyl]cyclohexanone (DAMC) in Tramadol (as active substance or active ingredient in pharmaceutical formulations) is described. The method is based on the derivatisation of 2-[(dimethylamino)methyl]cyclohexanone with 2,4-dinitrophenylhydrazine (2,4-DNPH) in acidic conditions followed by a reversed-phase liquid chromatographic separation with UV detection. The method is simple, selective, quantitative and allows the determination of 2-[(dimethylamino)methyl]cyclohexanone at the low ppm level. The proposed method was validated with respect to selectivity, precision, linearity, accuracy and robustness.

journal_name

J Pharm Biomed Anal

authors

Medvedovici A,Albu F,Farca A,David V

doi

10.1016/j.japna.2003.07.003

subject

Has Abstract

pub_date

2004-01-27 00:00:00

pages

67-74

issue

1

eissn

0731-7085

issn

1873-264X

pii

S0731708503004813

journal_volume

34

pub_type

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