Dissertation > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > Production of organic compounds in drug

Study on Taurine Production Monitoring and Its Quality by HPLC

Author YangJie
Tutor LiuYongQiong
School Wuhan Institute of Technology
Course Biochemical Engineering
Keywords Taurine High Performance Liquid Chromatography Monitor Production Quality Research
Type Master's thesis
Year 2006
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Taurine (Taurine, Tau) is the unique physiological and pharmacological functions of non-protein amino acid, is one of the important amino acids necessary for human, have been widely used in medicine, food and other industries. Tau production industrialization in China since the early 1980s has been the development of fast chemical synthesis Tau method amounted to more than ten kinds. Tau production industry today which ethanolamine (monoethanolamine, MEA) synthesis become readily available raw materials, milder reaction conditions using a method. Obtained by this method the yield is low, the quality of instability, on the other hand, China's production of Tau are mainly exported to Europe, America, Japan and other developed countries, these countries are often based on national pharmacopoeia specifications requirements Tau product quality, that is, domestic Tau The products must also meet the quality requirements of foreign demand. Therefore, the priority is how to improve the Tau yield and product quality. This thesis, for this purpose, to explore the high-performance liquid chromatography (HPLC) detection of Tau 2 - aminoethyl sulfate (2-aminoethyl hydrogen sulfate, AHS) and MEA content method, and methodological study to determine the the feasibility of this method. Then applied to production monitoring and improvement of the production process of the Tau, the yield increased to 65% from 52%, the product meets the Tau export quality requirements. The main work is as follows: 1. Tau and AHS content was measured before the HPLC column derivatization screened better internal standard D and methodological study. The qualitative and quantitative analysis, comparing the HPLC internal standard method and the difference of the external standard method, the establishment of the internal standard method HPLC column derivatization simultaneous determination of the the Tau and AHS content analysis method. 2. HPLC column derivatization method for the determination of the content of the MEA, methodological study, the concentration of the MEA good linear relationship within the range of 0.005 ~ 0.8g / L, the correlation coefficient (r) was 0.9999, the detection limit of 9.87 × 10 -8 g / L, recovery was 102.27%, relative standard deviation (RSD) was 1.18% (n = 5). Compared with the acid-base titration, this method is not only simple, high sensitivity, and interference from other impurities can be excluded, the results are accurate and reliable. 3. According to the Tau export quality requirements with reference to the 2005 edition of the Chinese Pharmacopoeia (ChP2005), United States Pharmacopoeia 29th edition (USP29th) and Japanese Pharmacopoeia Fourteenth corrections Edition (JP14th), developed the Tau quality corporate standards. 4. The above analysis method used in the production process monitoring, optimized process scheme is proposed and implemented. Results of the Tau yield increased to 65% from 52%, content of not less than 99.00%, and other quality indicators meet elaborated in this paper Tau quality corporate standards, in line with the requirements of export quality. HPLC column derivatization detection Tau and AHS internal standard method, more accurate, more reliable, according to the authors' knowledge, at home and abroad not been reported; established HPLC method for determination of the content of the MEA compared with the external standard method at home and abroad has yet to see reports; HPLC method for monitoring the Tau the production process but also the absence of relevant reports.

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