Bioequivalence Analysis of Sildenafil in Human Plasma Using LC-MS/MS: Method Development, Validation, and Volunteer Study Results
Keywords:
Bioequivalence, Sildenafil, LC-MS/MS, Human Plasma, Pharmacokinetics, Analytical Validation, Method DevelopmentAbstract
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 1200 parts per billion (ppb), with a weighting factor of 1/X applied to enhance accuracy. Analytical method validation was conducted following ICH M10 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.
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References
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