呋布西林钠有关物质HPLC测定方法的建立

发布时间：2018-06-27 14:09

  本文选题：呋布西林钠 + 有关物质　； 参考：《药学学报》2015年12期

【摘要】：呋布西林钠是目前仅在中国上市使用的半合成广谱抗生素,对多种革兰阳性菌及革兰阴性菌均有良好抗菌活性。由于合成工艺相对复杂等因素,对呋布西林钠的深入研发一直处于相对停滞状态,目前,现行有效的质量标准仅为1989年版的卫生部药品标准,其中采用容量法测定含量,且未对有关物质进行控制。据多篇文献报道,呋布西林钠中可能含有大量的呋布西林钠同分异构体,对其生物活性存在较大争议。为更好的控制呋布西林钠产品的质量,本研究建立了适用于呋布西林钠有关物质检查的HPLC分析方法。采用C18柱,柱温35℃,以梯度洗脱的方式,在225 nm下对其有关物质进行测定。通过方法学验证,保证了该系统的可靠性和准确性,并通过制备主要有关物质,对各有关物质的结构、生物活性和色谱行为进行了确证,为合理制定质控限度提供了充分的数据支撑。
[Abstract]:Furobuxicillin sodium is a semi-synthetic broad-spectrum antibiotic which is only used in China. It has good antibacterial activity against many Gram-positive bacteria and Gram-negative bacteria. Because of the relative complexity of the synthetic process, the deep research and development of furobuxicillin sodium has been relatively stagnant. At present, the current effective quality standard is only the medicine standard of the Ministry of Health in 1989, in which the content is determined by volumetric method. And the related substances are not controlled. According to many literatures, furobuxicillin sodium may contain a large number of isomers of furobuxicillin sodium, and its biological activity is controversial. In order to control the quality of furobuxicillin sodium, a HPLC method was established for the determination of furobuxicillin sodium related substances. The related substances were determined by gradient elution at 225 nm on C _ (18) column at 35 鈩，

本文编号：2074166