ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

HPLC analysis of a syrup containing nimesulide and its hydrolytic degradation product

Milan Mokrý, Jiří Klimeš, and Jana Pechová

Department of Pharmaceutical Chemistry and Drug Analysis, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic

E-mail: milan.mokry@faf.cuni.cz

Received: 1 April 2009  Revised: 4 September 2009  Accepted: 2 October 2009

Abstract: The present paper deals with the evaluation of nimesulide, 2-phenoxy-4-nitroaniline, the main hydrolytic degradation product of nimesulide, of methylparaben and propylparaben, and eventually of 4-hydroxybenzoic acid by HPLC with UV detection at 254 nm in syrup as a pharmaceutical formulation. HPLC analysis was employed on the reversed phase C18 with methanol and 0.01 M dibasic ammonium phosphate (ρ _r = 60: 40, pH 4.0). Validation was performed using standards and a pharmaceutical preparation containing the compounds described above.

Keywords: nimesulide - degradation product - pharmaceutical formulation - HPLC

Full paper is available at www.springerlink.com.

DOI: 10.2478/s11696-010-0001-2

Chemical Papers 64 (3) 405–408 (2010)