The Quality Study Of Riperidone By HPCE

Capillary electrophoresis (CE) is a new technique of separation and analysis regrouping different modes of separation, which has raised worldwide interest during recent years and many applications in the separation. In this paper, determination of risperidone and pharmacokinetic study by capillary electrophoresis were studied. The application of CE with the advantages of lower cost, high efficiency and fast separation in analytical technology were also studied in this dissertation.The fundamental principle, characteristics, separation modes and detection methods of capillary electrophoresis were introduced in this article. And the applications and progress of capillary electrophoresis in analysis were summarized.In this paper, A high performance capillary electrophoresis method was established for the determination of risperidone and the related substances in raw material and its tablets. The optimal condition was 30mmol/L phosphate (pH=5.0) as running buffer at the detection wavelength of 280 nm, separation voltage of 20 kV and the injection time of sample for 10s. The calibration curve for risperidone was linear in the concentration range of 0.08mg/mL～1.0mg/mL.and the average recovery was 99.38% . In the light of 2005 pharmacopoeia, the stability of risperidone and its tablets preparated in lab were studied by capillary electrophoresis method. The result of this study was risperidone with good stability was not sensitivity of heat, temperature and humidity. The three batches of risperidone and its tablets had good stability with the tests of acceletation and long. With the commercial common risperidone tablet as the reference , the pharmacokinetics study of self-prepared risperidone was performed in six SD rats.This paper achieved a further study in the analysis field of CE. Firstly, a method for determination of Melamine in dairy products was established.in this paper. Separation condition was investigated and optimized. Melamine in dairy products can be determinate under the optimized condition: 30mmol/L phosphate buffer (pH=5.0), the UV detection wavelength was 240nm and separation voltage at 10kV. The linear range of Melamine was 10.0μg/mL～50.0μg/mL and the average recovery was 97.04%. The method is simple, rapid and sensitive with good repeatability, and can be used for content determination of Melamine. Secondly, a method of separation of repaglinide and its enantiomers by high-performance caplliary electrophoresis was also established. Effects of several factors were investigated such as the concentration and pH of running buffer, additive, operation voltage. Repaglinide and its enantiomers can be separated under the optimized condition: the running buffer was 25mmol/L sodium tetraborate decahydrate-30mmol/L hydroxypropyl-β-CD (pH=9.0), UV detection was 245nm, separation voltage was 10kV and the injection time of sample was 5s.