| For the high sensitivity and selectivity, mass spectrometry has become one of the most important techniques in analytical area. It can well provide the information about quality and structure of molecular, especially in qualification of organic compounds and reaction monitoring, and its application was also extended by combining with other analytical techniques, such as chromatography. Recently, the liquid-chromatography tandem mass spectrometry (LC/MS/MS) has played an important role in pharmaceutical analysis and other areas.In this dissertation, we mainly provided some methods for determining the tropisetron and setastine in human serum and studied the bioequivalence of these drugs in two different formations.1. By optimizing the condition of chromatography and mass spectrometry, we built and validated a fast method to determine the tropisetron in human serum. The analysis was performed on the Phenomenex Synergi Fusion-RP C18 column (100 mm×2.0 mm I.D. 4μm) using acetonitrile -13 mM ammonium acetate - acetic acid (30:70:0.035, v/v) as the isocratic mobile phase. The method was successfully used to characterize the pharmacokinetic profiles of tropisetron in 20 healthy volunteers after an intravenous infusion of tropisetron, and it was proved to be bioequivalent for two different tropisetron formulations.2. A sensitive method was found to determine the setastine by using LC/MS/MS. The linear of this method ranged from 0.032 to 10 ng/mL, the recovery is between 80.8% and 91.9%, both the inner and inter-precision are less than 15%. This method was applied in determining the setastine in 20 healthy volunteers'serum, and the result showed the two different formulations have bioequivalent effect.
|
PDF Full Text Request