HPLC/MS/MS technology with its high sensitivity and high specificity replaces the LC technology, which has low resolving power and GC-MS, which has few analytical objects. HPLC/MS/MS technology will become a familiar analytical technology in the pharmaceutical analytical area, and it has a very notable effect in pharmacokinetic investigation. This dissertation is to use tri-quadrupole tandem mass spectrometer coupled with high-performance liquid chromatography technology for quantitative analysis of specific drugs, then, research the bioequivalent characters of the drugs.The dissertation consists of two main parts:1. By optimizing (the conditions of chromatography and mass spectrometry) and comparing (different methods of sample preparation), the appropriate conditions for quantity analysis of Amlodipine besylate using HPLC/MS technology had been found. This analytical method had high sensitivity and passed the method verification. Chromatographic condition was using a Synergi column (100×2.0 mm i.d., 4μm ; Phenomenex, USA) with a mixture of methanol and water (containing 0.15% ammonium acetate) (78 : 22, v/v) , and the flow-rate was 0.2 mL/min. The serum of 19 healthy volunteers had been quantified with the above analytical method.2. Developed a new method to quantify roxithromycin using HPLC/MS technology, For the Protein precipitation with methanol, The supernatant was reconstituted with mobile phase before injected into LC-MS/MS and analyzed. The concentration range of this method was 0.01~20.48μg/mL, the lower limit quantification was 0.01μg/mL and recovery ranged form 97.41 to 101.32%. The serum of 20 healthy volunteers had been quantified with the above analytical method , which had been validated.
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