Ankita Singh
pharmacy
October 2025
To measure naproxen in human plasma, a sensitive LC-MS/MS method must be developed and validated in order to acquire the appropriate pharmacokinetic and bioequivalence study. This paper describes the process of creating an LC-MS/MS method that analyzes naproxen using Zidovudine as an internal standard. In various chromatographic settings, the method was reproducible, sensitive, and selective. According to FDA guidelines, the validation was carried out using tests for linearity, accuracy, precision, recovery, and stability. Excellent chromatographic isolation, crisp peak resolution, and minimal plasma interference were demonstrated by the method. A linear response with a correlation coefficient (r2) of 0.9962 was discovered between 500.1 ng/mL and 100028.5 ng/mL. There was little variation in the recovery rate with Naproxen and internal standards, which was shown to be constant (>80%). Tests of the method's stability under various circumstances, including room temperature, freeze-thaw cycles, and prolonged storage, were conducted. This work presents a bioanalytical methodology that is suitable for bioanalytical research and may be used to measure the amounts of naproxen in blood plasma in both preclinical and clinical studies.
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