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The related impurities Research vinorelbine tartrate

Author: JinMeiChun
Tutor: RenQiLong
School: Zhejiang University
Course: Chemical Engineering
Keywords: Vinorelbine Tartaric acid Control of impurities Methyl Changchun bases Semi-synthetic Ammonium formate Photodegradation products Anti-cancer drugs Preparative separation
CLC: TQ464
Type: Master's thesis
Year: 2005
Downloads: 304
Quote: 2
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Abstract


Vinorelbine (vinorelbine, Navelbine) is a the Changchun bases developed by Pierre Fabre new semi-synthetic anticancer drugs . In the process of preparing a raw material , the product of synthesis and preservation, etc., are different degrees Strip into some impurities, to control the generation of impurities , or take other measures to be removed is the most important part of pharmaceutical quality . In this study, vinorelbine tartrate related impurities and degradation impurities as the object of study . Through the creation of high-performance liquid electrospray ionization mass spectrometry coupled with analytical methods . Columns VP-ODS150 * 4.6mm, mobile phase 0.05M ammonium formate the PH4.2 buffer - methanol ( 47:53) , flow rate 1.5ml/min , detection wavelength 267nm , column temperature of 35 ° C , the the MS ion hydrazine ESI-MS -MS online testing . The results showed that the establishment of the LC-MS determination of related substances method is simple and reproducible , and provides a basis for the evaluation of vinorelbine tartrate quality . Tartaric acid bulk drugs vinorelbine four unknown impurity by preparative separation is determined by the NMR structure of 21'-O demethylation vinorelbine ,23-O demethylation vinorelbine 6' -N A base vinorelbine ,17-Br on behalf of vinorelbine . Length vinorelbine tartrate impact factor test light, heat, humidity, acid , alkali , oxidation , reduction degradation of the samples , respectively . The experiments show that the samples are very unstable in light conditions , the thermal degradation conditions . Photodegradation products mainly light degradation impurities ,23- 0 demethylation vinorelbine ; 21' -0 demethylation vinorelbine 6' - N-methyl vinorelbine compared with the thermal degradation of impurities ; while the acid and alkaline degradation only produce an obvious impurities structure is presumed to 4-0 deacetyl vinorelbine ; 17 brominated vinorelbine compared with the byproducts of the process . Trial by influencing factors analysis of possible conditions related impurities in the sample , and provide the necessary theoretical basis for the quality control of the process control and sample preservation .

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