DOI: 10.21276/ajptr
Fri, 24 May 2019

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.


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).

[PDF]   Viewed: 1324   Downloaded: 227
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter