Abstract

CONTEMPORANEOUS BIOANALYSIS OF BUPROPION AND HYDROXY- BUPROPION IN HUMAN PLASMA BY SLC-MS-MS

Praveena Rathod and Nagarajan Janaki Sankarachari Krishnan*

ABSTRACT

Developed the simple, rugged, precise, accurate method has been defined for the development and validation of contemporaneous bioanalysis of Bupropion and Hydroxy bupropion (metabolite) in human plasma by SLC-MS-MS. Separation of the Bupropion and Hydroxy bupropion were effected by using Zorbax XDB Phenyl column (5μ, 75 x 4.6mm) with the following mobile phase containing cyanomethane : 10mM ammonium formate (80:20 v/v) pH adjusted to 3.00. Eluent was flowed 1ml/min, and injection volume of the sample was 5.0μl and the column temperature fixed as 40ºC. The retention time of Bupropion (BPPN), Hydroxy-bupropion (BPHN) and Bupropion-D9 (BPD9) was found to be 1.54, 1.43 and 1.57Min, respectively. API 4000 was configured with lab solution data solution, Triple quadrupole analyzer, ESI interface. The Bupropion, Hydroxy bupropion and bupropion –D-9 were extracted by the aqua-organic extraction method. The defined method was performed and validated as per the bioanalytical method validation suggested by USFDA. Linearity and range for the bupropion and hydroxy-bupropion were fit between 1.688 to 500.573ng/mL and 10.073 to 2986.607ng/mL respectively. The defined method shows very good recovery, sensitivity and having shorter runtime for the separation of bupropion and hydroxy-bupropion from the plasma. All the validation parameters are within the prescribed range of 85-115%. This method can apply for Therapeutic Drug Monitoring. Pharmacokinetic, Bioequivalence and Bioavailability Studies contains Bupropion and Hydroxy- bupropion.

Keywords: Concurrent bioanalysis, Bupropion, Hydroxy-Bupropion, Human Plasma, SLC-MS/MS.