RESEARCH PAPER
DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR ESTIMATION OF OXCARBAZEPINE IN SPIKED HUMAN PLASMA: SYNTHESIS AND CHARACTERIZATION OF ITS ACTIVE METABOLITE
 
More details
Hide details
1
Department of Pharmaceutical Analysis, MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, India
CORRESPONDING AUTHOR
Sandeep S. Sonawane   

Department of Pharmaceutical Analysis, MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, 422003, Nashik, India
Publish date: 2019-02-07
 
Eurasian J Anal Chem 2018;13(6):em
KEYWORDS
TOPICS
ABSTRACT
Background:
A simple, precise and accurate HPLC-UV method was developed and validated for the quantitation of oxcarbazepine (OXZ) in human plasma.

Material and methods:
The OXZ and erlotinib (ERL) (internal standard) were extracted from human plasma using liquid-liquid extraction. The extraction efficiency of drug and internal standard from plasma were evaluated in different organic solvents and effect of pH modifier were studied. The separation was achieved on C18 (250 × 4.6 mm, 5 µm) column using methanol: 20 mM potassium phosphate buffer (pH 3.0) (60:40 %, v/v) at 237 nm. The flow rate was kept constant at 1mL/min throughout the analysis. To select the optimal calibration model, different weighting factors were evaluated.

Results:
The calibration model with weighing factor, 1/x2 was found optimal with minimum % relative error and most random distribution around x-axis. The calibration curve was linear in the range of 100-3200 ng/mL. The method was validated as per US-FDA guidelines with respect to selectivity, accuracy, precision, % recovery and stability. Further, the 10,11-dihydro-10-hydroxy carbamazepine (10-MHD); active metabolite of OXZ was synthesized and characterized by GC-MS. The extraction efficiency of 10-MHD in human plasma was compared with OXZ using optimized LLE method.

Conclusions:
The present method is economic compared to the reported methods.

eISSN:1306-3057