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 liquidliquid 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.
Highlights
Naproxen (+)-2-(6-methoxy-2-naphthyl) propionic acid is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic properties often preferred to acetylsalicylic acid because of its better absorption following oral administration and fewer adverse effects [1,2,3,4,5]
In optimizing the chromatographic conditions, the ammonium acetate buffer solution was adopted in the mobile phase of the HPLC in order to suppress the tailing phenomena of chromatographic peaks of naproxen and zidovudine
Experimental results showed that acidifying the mobile phase with formic acid contributed to improve peak shapes of naproxen and zidovudine
Summary
Naproxen (+)-2-(6-methoxy-2-naphthyl) propionic acid is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic properties often preferred to acetylsalicylic acid (aspirin) because of its better absorption following oral administration and fewer adverse effects [1,2,3,4,5]. Anti-inflammatory effects of naproxen are generally thought to be related to its inhibition of cyclo-oxygenase and consequent decrease in prostaglandin concentrations in various fluids and tissues [2]. The coupling of HPLC with mass spectrometry (LC-MS/MS) is generally accepted as the preferred technique for quantitating small molecule drugs and metabolites in biological matrices, since this technique is highly selective and sensitive [21,22]. LC-MS/MS technique was successfully employed to provide a satisfactory sensitivity and selectivity in a desirable time of chromatographic run
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