All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Abstract

Development and Validation of a HPTLC Method for Rivaroxaban in Human Plasma for a Pharmacokinetic Study

Author(s): A. H. SHUKLA, P. J. SHAH, P. P. DEDHIYA*, B. A. VYAS AND S. A. SHAH
Maliba Pharmacy College, Maliba Campus, Gopal Vidyanagar, Bardoli, Gujarat, India-394 350

Correspondence Address:
Maliba Pharmacy College, Maliba Campus, Gopal Vidyanagar, Bardoli, Gujarat, India-394 350,E-mail: praful.dedhiya@utu.ac.in


The present study is concerned with the development and validation of a bioanalytical method for estimation of rivaroxaban in human plasma using high performance thin layer chromatography. The chromatographic separation was achieved on pre-coated silica gel 60F254 thin layer chromatography plate using toluene:ethylacetate:methanol (6:3:1, % v/v/v) as a mobile phase. Detection was carried out at 284 nm. A compact spot was obtained with an Rf value of 0.44±0.02. The linearity was found over the concentration range of 25-125 ng/band in human plasma. The relative standard deviation for repeatability of sample application and sample measurement was 0.60 and 1.65 %, respectively. The relative standard deviation for intraday and interday precisions was in the range of 1.37 to 1.85 % and 1.03 to 2.77 %, respectively. The limit of quantitation was 8.00 ng/band and the limit of detection was 2.64 ng/band. Percent recovery of rivaroxaban was in the range of 66.95-69.03%. This method was applied to a pharmacokinetic study of rivaroxaban. The Cmax and tmax for test and marketed formulation were found to be 63.83 and 47.3 ng/ml and 3 and 4 h respectively. The area under the curve0-t for test and marketed formulation were found to be 290 and 219.0 ng/ml.h, respectively. The t1/2 for test and marketed formulation was found to be 6.87 and 6.64 h.

Full-Text | PDF

 
 
Google scholar citation report
Citations : 69022

Indian Journal of Pharmaceutical Sciences received 69022 citations as per google scholar report