Tue, 21 Nov 2017

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

M. Kishore*1, B. VijayaKumar2, Y. NarasimhaReddy3.

1. Research Scholar of Jawaharlal Nehru Technological University Kakinada, Kakinada, A.P, India, PIN: 533001.

2. Jangaon Institute of Pharmaceutical Sciences, Jangaon, Waranal (D), Telangana, India. PIN: 506167

3. University College of Pharmaceutical Sciences, Warangal, Telangana, India, PIN: 506009.


ABSTRACT

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.

Keywords: Sulfasalazine, methanol, ammonium acetate buffer, HPLC-UV method, t1/2, Cmax, Tmax, and AUC (0~t).


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