Tropical Journal of Pharmaceutical Research

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Original Research Article

Development and Validation of Liquid Chromatography-Mass Spectroscopy/Mass Spectroscopy Method for Quantitative Analysis of Naproxen in Human Plasma after Liquid-Liquid Extraction

NK Sahoo¹*, M Sahu¹, PS Rao¹ and G Ghosh²

¹Yalamarty Pharmacy College, Tarluwada, Visakhapatnam. Andhra Pradesh, 530052, ²School of Pharmaceutical Sciences, Siksha 'O' Anusandhan University, Bhubaneswar, Odisha, 751003, India

*For correspondence: Email: sahoo.nalini@gmail.com; Tel: 09550741536, 09396772373

Received: 3 December 2013 Revised accepted: 28 July 2014

Tropical Journal of Pharmaceutical Research, September 2014; 13(9): 1503-1510

http://dx.doi.org/10.4314/tjpr.v13i9.17

Abstract

Purpose: To determine naproxen levels in human plasma using a new liquid chromatography-Mass spectroscopy/Mass spectroscopy (LC-MS/MS) method that involves a simple and single step extraction procedure using low-cost reagents.

Method: A novel liquid chromatography–tandem mass spectrometry method for the quantitative determination of naproxen in human K2-EDTA plasma in negative ion mode was employed and validated using zidovudine as internal standard (IS). Sample preparation was accomplished by liquid-liquid extraction technique. The eluted samples were chromatographed on Zorbax Eclipse XDB phenyl 4.6 × 75 mm, 3.5 µm column (Agilent Technologies) using a mobile phase consisting of acetonitrile: 20 mM ammonium acetate (90:10 v/v).The injection volume was 15 µL and the total run time was 3.0 min. The method was validated for all parameters for naproxen.

Results: The method showed selectivity and linearity over a concentration range of 500.1 ng/mL to 100028.5 ng/mL The validation data indicate precision and accuracy of 90 - 110 % and < 15 %), respectively, as well as recovery (80.63 %), stability (mostly stable) and carryover (0 %).

Conclusion: A rapid and selective LC-MS/MS method for the quantification of naproxen in human plasma has been developed and can be used in therapeutic drug monitoring of this drug as well as in bioequivalence studies of the drug.

Keywords: Naproxen, Therapeutic drug monitoring, Mass spectrometry, Human plasma