چکیده مقاله
This study presents a detailed bioequivalence analysis of naproxen 500 mg tablets through liquid chromatography tandem mass spectrometry LC MS/MS in human plasma samples The methodology adhered to EMEA and ICH M15 guidelines, focusing on specificity, carry over effects, lower limit of quantification LLOQ , calibration curve linearity, precision, accuracy, matrix effects, and stability Calibration was established over a concentration range of 5 5–26 ppm, yielding robust linearity R > 5 22 Analytical validation indicated LLOQ as 5 5 ppb, with a signal to noise ratio exceeding 15, ensuring sensitivity for bioequivalence assessment Precision and accuracy were evaluated for intra day and inter day variability across low, medium, and high QC levels, achieving relative standard deviations RSDs within acceptable limits < 15% Stability testing, including freeze thaw, short term, and long term conditions, confirmed method reliability Matrix effect evaluations demonstrated minimal interference, with extraction recovery exceeding 25% Pharmacokinetic profiling revealed key metrics such as Cmax and Tmax, confirming bioequivalence between test and reference formulations The results validate the robustness and applicability of the proposed LC MS/MS method for bioequivalence studies, contributing to high throughput analytical workflows in pharmaceutical research
کلیدواژهها
نویسندگان
Dariush Omidfar
Payesh Darou Zist Azma Company, East Azerbaijan, Tabriz, Iran
Ahad Sheikhloo
Payesh Darou Zist Azma Company, East Azerbaijan, Tabriz, Iran
شیوه ارجاع
Omidfar, Dariush and Sheikhloo, Ahad,1403,Comprehensive Bioequivalence Analysis of Naproxen 500 mg in Human Plasma Using Advanced LC-MS/MS Techniques,Third International Conference for Iranian Hygienics and Health Sciences Students,Tehran
ارائهشده در
مجموعه مقالات سومین کنفرانس بین المللی دانشجویان بهداشت و علوم سلامت ایران30 بهمن 1403 · تهران