Determination of Pharmacokinetic Parameters of Sulfasalazine Enteric Coated Tablets In Human Healthy Volunteers

To establish an HPLC method for the determination of sulfasalazine in human plasma and to study the pharmacokinetics in Indian healthy volunteers following oral administration of sulfasalazine enteric-coated tablets.  In the study, 08 volunteers were administered with single oral dose of 500mg of sulfasalazine enteric-coated tablets with marketed reference product. The plasma concentrations of sulfasalazine were determined by HPLC-UV method. Chromatography was carried out on C-18 column with mobile phase comprising methanol and ammonium acetate buffer (pH 7.0) in the ratio of 48:52 pumped at a flow rate of 0.8 ml min−1. The retention time for sulfasalazine were 12.2±0.05 min, the pharmacokinetic parameters were calculated with aid of the software DAS2.1.1. The calibration curve of sulfasalazine was linear in the range from 1.00 to 10.00μg/ml (r2=0.998). The main pharmacokinetic parameters of sulfasalazine enteric coated tablets with marketed reference product were as follows: half life were (7.51±0.54) and (7.32±0.72) h, Cmax were (7.7125±1.0125) and (7.6±0.30)μg/ml, Tmax were (6.38±0.62) and 6.38±0.62)h, AUC(0~t) were (84.92±20.25) and (79.39±19.45)μg·h/ml, respectively.