چکیده مقاله
This study presents a detailed bioequivalence analysis and method validation for quantifying tizanidine hydrochloride TIZ in human plasma using liquid chromatography tandem mass spectrometry LC MS/MS The analytical method incorporates internal standardization with amlodipine besylate, achieving high sensitivity and specificity through multiple reaction monitoring MRM A robust linear calibration curve 55–3255 ppt was established, weighted by 1/x, with a correlation coefficient exceeding 5922 Analytical method validation adhered to ICH M 15 guidelines, ensuring accuracy, precision, specificity, and robustness The liquid liquid extraction protocol optimized sample preparation, while system suitability was confirmed through key performance parameters, including retention time stability and signal to noise ratios Bioequivalence was evaluated in a single dose crossover study with healthy volunteers, comparing test and reference formulations Pharmacokinetic parameters such as maximum plasma concentration Cmax , time to reach Cmax Tmax , and area under the curve AUC were statistically analyzed, meeting regulatory acceptance criteria The methodology demonstrated negligible matrix effects and interference, enabling precise quantification of TIZ at therapeutic concentrations These findings confirm the reliability of this validated LC MS/MS method for bioequivalence studies and therapeutic drug monitoring of tizanidine
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 and Analytical Validation of Tizanidine in Human Plasma Using 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