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欧洲药典中对呋塞米不包括有关物质的色谱试验,虽有游离芳伯胺的比色试验,还应考虑限制所有已知的潜在杂质。美国药典(USP)ⅩⅫ版发表了液相色谱法,从呋塞米中分离出了杂质:2-氨基-4-氯-5-氨磺酰苯甲酸(Ⅰ)、2,4-二氯-5-氨磺酰苯甲基(Ⅱ)、2-氯-4-(2-糠氨基)-5-氨磺酰苯甲酸(Ⅲ)和2,4双(2-糠氨基)-5-氨磺酰苯甲酸(Ⅳ)。该法需用两个杂质对照品(Ⅰ和Ⅲ),还因这些杂质的吸光度差异大,而在两个波长检测。本文仅用一个波长检测,采用反相离子对液相色谱法,从呋塞米中分离已知的潜在杂质。仪器液相色谱仪为Spectra-physics8000型泵,20μl进样圈,惠普公司1140A检
Chromatographic tests in the European Pharmacopoeia on substances not covered by furosemide should be considered to limit all known potential impurities, despite the colorimetric assay of free primary amines. The U.S. Pharmacopeia (USP) version XXII publishes liquid chromatography, which separates impurities from furosemide: 2-amino-4-chloro-5-sulfamoylbenzoic acid (I), 2,4- 5-sulfamoylbenzyl (II), 2-chloro-4- (2-furfurylamino) -5- sulfamoylbenzoic acid (III) and 2,4 bis (2-furfurylamino) -5- Sulfonyl benzoic acid (IV). The method requires two impurity controls (I and III) and also detects at two wavelengths due to the large difference in absorbance of these impurities. This article uses only one wavelength detection, using reversed-phase ion-pair liquid chromatography, the separation of known potential impurities from furosemide. Instrument LC for the Spectra-physics8000 pump, 20μl injection loop, Hewlett-Packard 1140A seized