Method Validation of Esomeprazole Analysis in Human Plasma using High Performance Liquid Chromatography–Photodiode Array
Yahdiana Harahap1, Ahmad Erik Baskara1, Harmita h1
- 1Faculty of Pharmacy, University of Indonesia, UI Depok Campus, Depok, 16424, INDONESIA.
Received: 21-12-2016; Revised: 07-01-2017; Accepted: 13-01-2017.
Volume 9, Issue 1S · pp. s24–s28 · PUBLISHED · DOI: 10.5530/jyp.2017.1s.7
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.
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Harahap, Y., Baskara, A. E., & h, H. (). Method Validation of Esomeprazole Analysis in Human Plasma using High Performance Liquid Chromatography–Photodiode Array. Journal of Young Pharmacists, 9(1S), s24–s28. https://doi.org/10.5530/jyp.2017.1s.7