Home J Young Pharm, Vol 9/Issue 1s/2017 Method Validation of Esomeprazole Analysis in Human Plasma using High Performance Liquid Chromatography–Photodiode Array

Method Validation of Esomeprazole Analysis in Human Plasma using High Performance Liquid Chromatography–Photodiode Array

by services@emanuscript.in
Published on:March 2017
Journal of Young Pharmacists, 2017; 9(1s):S24-S28
Original Article | doi:10.5530/jyp.2017.1s.7
Authors:

Yahdiana Harahap, Ahmad Erik Baskara, Harmita

Faculty of Pharmacy, University of Indonesia, UI Depok Campus, Depok, 16424, INDONESIA.

Abstract:

Objective: This research aimed to develop sensitive, simple, and selective methods for determination of esomeprazole in human plasma using lansoprazole as internal standard by high performance liquid chromatography. Method: The analytical separation was performed on C-18 column (Waters, Sunfire™ 5 μm; 250 x 4.6 mm), column temperature 40°C. The mobile phase used acetonitrile – phosphate buffer pH 7.6 (40: 60% v/v) with a flow rate of 1.00 mL/min; and photodiode array detector at a wavelength of 300 nm. Esomeprazole and lansoprazole were extracted by liquid-liquid extraction using dichloromethane. Results: The method had a chromatographic run time of 10 min and linear calibration curve over the range of 5.0-450 ng/mL with a correlation coefficient (r) of 0.999 or better. The sensitivity, specificity, linearity, precision and accuracy, recovery and stability were validated for esomeprazole in human plasma. Conclusion: The results of validation fulfilled the acceptance criteria of validation method based on EMEA Bioanalytical Guideline 2011.

Key words: Esomeprazole, HPLC, Optimization, Validation, Plasma.

© 2025, Journal of Young Pharmacists.  All Rights Reserved. | Powered by Manuscript TechnoMedia LLP.