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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。
Furosemide sodium is currently only used in China semi-synthetic broad-spectrum antibiotics, a variety of Gram-positive bacteria and Gram-negative bacteria have good antibacterial activity. Due to the complexity of the synthesis process and other factors, the in-depth research and development on furazolidinyl sodium has been in a relatively stagnant state. At present, the currently valid quality standard is only the 1989 version of the Ministry of Health pharmaceutical standards, in which the volumetric method is used to determine the content, Material control. It has been reported in many articles that there may be a large amount of furosemide sodium isomers in the furazolidin sodium, and there is much controversy about its biological activity. In order to better control the quality of the product made of furazolidin sodium, HPLC analysis method for the determination of related substances of furazolidin sodium was established in this study. Using C18 column, the column temperature 35 ℃, gradient elution mode, at 225 nm its related substances were determined. Through the verification of methodology, the reliability and accuracy of the system are guaranteed, and the structure, biological activity and chromatographic behavior of the related substances are confirmed by preparing the main related substances, which provides sufficient data for reasonably setting the quality control limits support.