DEVELOPMENT AND VALIDATION OF A METHOD FOR DETERMINATION OF DICLOFENAC SODIUM IN PLASMA BY HPLC

TF07

Aguiar, FA.; Gaitani, CM.

Department of Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences, University of São Paulo, Ribeirão Preto, Brazil

Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic and antipyretic properties. It is widely used in the long-term treatment such as rheumatoid arthritis, and osteoarthritis. Nevertheless, it produces a relatively high incidence of gastrointestinal side effects such as irritation, ulceration and eventually perforation in the gastric wall. Several analytical methods have been described for the quantification of diclofenac sodium in plasma based on different extraction procedure. In this study, the development and validation of a high-performance liquid chromatography (HPLC) method for determination of diclofenac sodium concentration in plasma for pharmacokinetic studies is described. The procedure used for sample preparation was based on the liquid-liquid extraction by using a mixture of hexane:diethyl ether (1:1, v/v) as extracting solvent and the analysis of diclofenac sodium was carried out on a C-18 analytical column (125 mm × 4.8mm i.d., 5 μm particle size, LinchroCART^®) using a mobile phase consisting of acetic acid (pH 2.5, 0.7 mol/l):acetonitrile (1:1, v/v), at a flow-rate of 1 ml/min. The method showed a recovery of 100.3% and the coefficients of variation in the precision and accuracy studies were below 12%. O proposed method presented quantitation limit of the 0.1 μg/ml and was linear up to a concentration of the 60 μg/ml and it is enough for application to pharmacokinetic studies