Acta Pharm. 52 (2002) 37-43

Original research paper  
 

Validation of the HPLC method for model determination of fenoprofen
in conjugates with PHEA

BAREND BONESCHANS,1* TANIA VAN DER MERWE,1 ANITA WESSELS1 and  BRANKA ZORC2

fmsbb@puknet.puk.ac.za

1Centre for Quality Assurance of Medicines, P.B. X6001, Potchefstroom, 2520, South Africa
2Faculty of Pharmacy and Biochemistry, University of Zagreb, 10000 Zagreb, Croatia
Received August 3, 2001      Accepted January 2, 2002

An isocratic RP HPLC method for model determination of fenoprofen in PHEA-fenoprofen conjugates was developed and fully validated. The proposed method is a modification of the official HPLC method for fenoprofen in respect of the type of the stationary phase and mobile phase composition. The method was found to be specific, precise (RSD 0.9%), accurate (mean recovery 99.2%) and robust. Limit of detection was estimated at 0.02 mg mL-1 and the limit of quantification at 0.09 mg mL-1.

Keywords: fenoprofen, PHEA-fenoprofen conjugate, determination, HPLC, validation