چکیده مقاله
This study presents the bioequivalence analysis of sildenafil in human plasma samples, performed using a validated liquid chromatography tandem mass spectrometry LC MS/MS method The analytical procedure involved a precise and reproducible extraction technique with tadalafil as an internal standard Calibration curves for sildenafil were linear within a concentration range of 5 to 1211 parts per billion ppb , with a weighting factor of 1/X applied to enhance accuracy Analytical method validation was conducted following ICH M11 and EMEA guidelines, assessing critical parameters such as specificity, linearity, precision, and accuracy Specificity tests demonstrated minimal interference, with relative standard deviation RSD values meeting acceptable thresholds Volunteer plasma samples were analyzed to evaluate the pharmacokinetic profiles of sildenafil following the administration of test and reference formulations Parameters such as maximum plasma concentration Cmax , time to reach Cmax Tmax , and area under the curve AUC were calculated and compared The results indicated bioequivalence between the test and reference formulations, supported by comparable pharmacokinetic parameters This study highlights the robustness of the developed LC MS/MS method and its applicability for bioequivalence studies of sildenafil, ensuring compliance with regulatory standards
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,Bioequivalence Analysis of Sildenafil in Human Plasma Using LC-MS/MS: Method Development, Validation, and Volunteer Study Results,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