چکیده مقاله
This study details the development, validation, and application of a robust analytical method for quantifying mesalazine in human plasma using liquid chromatography tandem mass spectrometry LC MS/MS The method was optimized for specificity and sensitivity, achieving a lower limit of quantification LLOQ at 1 ppb, which complies with the International Council for Harmonisation ICH M11 and European Medicines Evaluation Agency EMEA guidelines Calibration curves were linear across a range of 1–161 ppb with a coefficient of determination R2 exceeding 0 9922 Analytical parameters, including precision, accuracy, carry over, and matrix effects, were rigorously validated, demonstrating reliable performance Short term and long term stability tests confirmed the analyte's robustness under varying conditions, including freeze thaw cycles The method's clinical relevance was evaluated through a bioequivalence study involving 26 healthy volunteers, who received test and reference formulations of mesalazine Plasma samples were collected at multiple intervals and analyzed to generate pharmacokinetic profiles, including key metrics such as maximum concentration Cmax and area under the curve AUC Results demonstrated comparable pharmacokinetic properties, confirming the bioequivalence of the test formulation with the reference product This validated method's high sensitivity and specificity make it suitable for both clinical and regulatory applications The use of a stable internal standard, diazepam, mitigated potential analytical errors, ensuring precise quantification of mesalazine This study not only underscores the method's robustness but also provides essential data supporting its utility in therapeutic monitoring, drug development, and regulatory compliance The findings contribute significantly to advancing the field of bioanalysis and ensuring drug safety and efficacy through rigorous evaluation methods
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,Analytical Method Validation and Bioequivalence Analysis of Mesalazine in Human Plasma via LC-MS/MS,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