Application of ultra performance lc-mass spectrometry/mass spectrometry method in the bioequivalence study of Sodium Valproate Sustained-Release Tablets
Objective Establish a detection methodology that can quickly,easily,and in large quantities analyze and detect the blood concentration of valproic acid,and can be applied to evaluate the bioequivalence of Sodium Valproate Sustained-Release Tablets in healthy volunteers.Methods Organize subjects to take the test and reference formulations of 0.5 g sodium valproate sustained-release tablets,collect blood samples,and prepare plasma samples.Determine the concentration of valproic acid in plasma using the established ultra performance lc-mass spectrometry/mass spectrometry(UPLC-MS/MS).Results Under fasting and postprandial conditions,both formulations were bioequivalence in terms of absorption rate and degree.Conclusion This experiment established an accurate and rapid UPLC-MS/MS method for detecting the content of valproic acid in human plasma samples.Two formulations have bioequivalence.
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