新型镇痛药S-1903原料药的有关物质检查及稳定性研究  

Related substances and stability of a new analgesic drug S-1903

作　　者：宋小容 杨国宝 姚青 高春生 王玉丽 孔晓龙[1] SONG Xiao-rong;YANG Guo-bao;YAO Qing;GAO Chun-sheng;WANG Yu-li;KONG Xiao-long(Pharmaceutical College of Guangxi Medical University,Nanning 530021,China;Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Academy of Mililary Sciences,Beijing 100850,China;School of Pharmaceutical Engineering,Shenyang Pharmacrutical University,Shenyang 117004,China)

机构地区：[1]广西医科大学药学院,南宁530021 [2]军事科学院军事医学研究院毒物药物研究所,北京100850 [3]沈阳药科大学制药工程学院,沈阳117004

出　　处：《军事医学》2021年第7期543-547,共5页Military Medical Sciences

基　　金：“重大新药创制”国家科技重大专项(2018ZX09711003-008-001)。

摘　　要：目的建立镇痛药S-1903中有关物质的高效液相色谱法(HPLC),并考察S-1903原料药在不同影响因素下的稳定性。方法采用CAPCELL PAK C18 MGⅡS5色谱柱,流动相为0.18%的冰醋酸溶液(三乙胺调pH至5.5)∶乙腈(80∶20,V/V,等度洗脱);流速为1 ml/min;检测波长为230 nm。考察S-1903在不同pH条件下、高温、高湿、强光的稳定性。结果S-1903与有关物质能很好地分离,所建立的有关物质检查方法经验证,专属性、重复性及稳定性均良好。S-1903固体状态在高湿条件下相对稳定;S-1903水溶液在高温、光照和pH 2.5~6条件下均不稳定。结论所建立的HPLC法适用于S-1903原料药的有关物质检查和稳定性研究。S-1903溶液的稳定性较差,该结果可为镇痛药S-1903及其相关制剂的研究提供一定依据。Objective To establish a HPLC method for determination of related substance in S-1903 and to investigate the stability of them affected by different factors.Methods The detection was performed on a CAPCELL PAK C18 MGⅡS5 column with mobile phase consisted of 0.18%HAC solution(pH adjusted to 5.5 with triethylamine)-acetonitrile(80∶20,V/V)(isocratic elution).The flow rate was set at 1 ml/min and the UV detection was perform at 230 nm.The stability of S-1903 under different pH,high temperature,high humidity,strong light and high temperature was investigated.Results S-1903 and related substances could be well separated.The developed method was further validated and proved to be sensitive,precise and stable.The S-1903 in solid state was stable relatively under high humidity,and its liquid state was unstable in high temperature and light and pH 2.5-6 conditions.Conclusion The method is applicable to the quality control,the stability of S-1903 solution is poor,which provides a certain basis for the study of S-1903 and its related preparations.

关 键 词：左旋四氢巴马汀 有关物质 稳定性 高效液相色谱 

分 类 号：R943[医药卫生—药剂学]