Quantification of Naproxen Sodium in biological sample by using UPLC-MS/MS method
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Author:
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SUMITHRA M, AYSHA JADEERA K A, YAMINI R, VIJEY AANANDHI M
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Abstract:
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The aim of our study is to develop a validated method for the determination of Naproxen sodium in biological solution by using liquid Chromatography –Mass Spectroscopy.
The solvent and mobile phase is selected by solubility studies. The Naproxen D3 as internal standard (IS). Chromatographic separation is achieved in a Phenomenex Zobrax C18 (150 x 4.6 mm, 5 mm) column. The separated compound is identified by Tandem mass Spectroscopy. The mixture of Methanol: 0.5% Ammonium Acetate [pH: 3.5] in the ratio of 50:50 v/v is used as a mobile phase. The 1.0 mL/min is used as a flow rate. The detection wavelength is 230nm. The calibration curve is linear and plotted in the concentration range of 30 to 80 ng/mL. The developed method is validated as per ICH guidelines. The developed method is complies the limits according to the FDA guidelines. The developed method is accurate, precise, sensitive method for determination of Naproxen from human plasma solution and formulation. The reported method is suitable for bioequivalence and pharmacokinetic studies.
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Keyword:
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Naproxen,Human Plasma,Validation,UPLC-MS/MS,Bioequivalence
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EOI:
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DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.425
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