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通过合成获得盐酸瑞芬太尼主要有关物质,确证其结构为4-(甲氧基羰基)-4-[(N-1-氧代丙基)苯胺基]-1-哌啶丙酸,并建立了高效液相色谱法测定盐酸瑞芬太尼中的有关物质。采用Kromasil氰基柱,流动相为0.03 mol/L磷酸二氢钾缓冲液(pH 3.0)-甲醇-乙腈(80︰16︰4),检测波长225 nm。盐酸瑞芬太尼及其主要有关物质在1～15μg/ml范围内线性关系良好。
The main related substances of remifentanil hydrochloride were obtained through the synthesis, and its structure was confirmed to be 4- (methoxycarbonyl) -4 - [(N-1-oxopropyl) anilino] A HPLC method was developed for the determination of related substances in remifentanil hydrochloride. The Kromasil column was used. The mobile phase consisted of 0.03 mol / L potassium dihydrogen phosphate buffer (pH 3.0) -methanol-acetonitrile (80:16:4). The detection wavelength was 225 nm. Remifentanil hydrochloride and its related substances showed good linearity in the range of 1 ~ 15μg / ml.