盐酸莫西沙星原料及片剂有关物质及稳定性分析  

Analysis of related substances and stability of moxifloxacin hydrochloride tablets

作　　者：崇小萌[1] 田冶[1] 王立新[1] 姚尚辰[1] 尹利辉[1] 刘颖[1] 许明哲[1] CHONG Xiao-meng;TIAN Ye;WANG Li-xin;YAO Shang-chen;YIN Li-hui;LIU Ying;XU Ming-zhe(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2022年第15期1531-1541,共11页Chinese Journal of New Drugs

摘　　要：目的:本文通过比较不同厂家盐酸莫西沙星原料及片剂的有关物质和晶型,分析其稳定性及影响稳定性的因素,为产品生产、包装及贮存条件提供指导。方法:采用反相液相色谱系统分析盐酸莫西沙星原料和片剂的杂质谱,采用粉末X衍射对原料晶型进行分析比较,并对所用辅料进行了分析,对片剂进行影响因素实验,对原料进行强制降解实验,并采用柱切换LC-MS方法对主要杂质进行结构确证。结果:确定了盐酸莫西沙星原料及片剂的杂质谱,各厂家原料均呈较好的晶型,影响因素实验中所有厂家片剂有关物质未见明显改变,确定了降解实验中2个主要杂质的结构。结论:盐酸莫西沙星片剂对高温、高湿及光照均稳定,确定了关键性杂质,用于分析原料及片剂在生产、包装和贮存过程中是否产生降解,以判断环境条件是否适宜。盐酸莫西沙星片剂在现有的生产及贮存条件下较为稳定。Objective: In this paper, raw materials, related substances of tablet and compound crystal types of moxifloxacin hydrochloride from different manufacturers were compared. The stability and factors affecting it were analyzed in order to provide guidance for the production, package and storage conditions of products. Methods: The impurity profile of moxifloxacin hydrochloride raw materials and tablets were analyzed by reversed-phase liquid chromatography. The crystal form of raw materials was analyzed and compared by powder X-diffraction. The applied excipients of tablets were also analyzed. The influencing factor testing was performed on the tablets, stress testing was performed on the raw materials, and the structure of main impurities was confirmed using column switching LC-MS. Results: The impurity profile of moxifloxacin hydrochloride raw materials and tablets were determined, and the raw materials from all manufacturers showed good crystal form. The related substances of tablets from all manufacturers did not change significantly in the influencing factor testing. The structures of two main impurities in the stress testing were determined. Conclusion: Moxifloxacin hydrochloride tablets were stable at high temperature, high humidity and light. The key impurities were determined, which is helpful to analyze whether the raw materials and tablets are degraded in the process of production, package and storage, and to judge whether the environmental conditions are suitable. Moxifloxacin tablets are stable under the current production and storage conditions.

关 键 词：盐酸莫西沙星 有关物质 稳定性 柱切换液质联用 

分 类 号：R943[医药卫生—药剂学]