DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF VORAPAXAR BY UPLC-MS/MS: APPLICATION TO A PHARMACOKINETIC STUDYAbstract
The validated analytical method was applied for estimation of vorapaxar in aqueous and human plasma with vorapaxar-D5 as an internal standard by using UPLC-ESI-MS/MS. The chromatographic separation was achieved with 5mM Ammonium Formate Buffer (pH: 4.0): Methanol: Acetontrile, (40:30:30, % v/v) using the Pursuit XRs-100Å, C18, 4.6 × 50 mm, 10 µm. The total analysis time was 3.5 min and flow rate was set to 0.2 ml/min. The mass transitions of vorapaxar and vorapaxar-D5 obtained were m/z 591.4®447.2 and 498.6®447.2. The standard curve shows correlation coefficient (r2) greater than 0.999 with a range of 0.01-200.0 ng/ml using the linear regression model. The developed method was applied successfully for studying the pharmacokinetics of vorapaxar in rabbits.
T. M. Rao, C. B. Reddy and P. S. Babu
Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India.
25 December 2019
23 January 2020
27 January 2020
01 February 2020