RP-HPLC法测定WF-208原料药有关物质
RP-HPLC determination of related substances in WF-208
分类号：
出版年·卷·期（页码）：2012,32 (7):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 建立测定噁二唑基哌嗪衍生物(WF-208)原料药有关物质的RP-HPLC方法,以控制其质量。 方法: 采用Diamonsil C18色谱柱(250 mm×4.6 mm,5 μm);流动相:乙腈-甲醇-水,梯度洗脱;流速:1.0 mL·min-1;检测波长:238 nm;柱温:30℃。 结果: WF-208能与合成过程中的2个主要中间体Ⅰ、Ⅱ和其他有关物质实现良好的分离,2个主要中间体Ⅰ、Ⅱ均在0.02~1.5 mg·L-1范围内呈良好的线性关系,检测限均为5 μg·L-1。 结论: 本法灵敏,专属性强,可用于WF-208原料药的质量控制。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish an RP-HPLC method for the determination of related substances in WF-208(derivative of oxadiazole piperazine). Methods: Diamonsil C18(250 mm × 4.6 mm, 5 μm) was adopted with acetonitrile-methanol-water as the mobile phase at the flow rate of 1.0 mL·min-1,the wavelength was set at 238 nm and the column temperature was 30℃. Results: The two main intermediates of WF-208 and other related substances were completely separated from WF-208. The linearity of two main intermediates was in the range of 0.02-1.5 mg·L-1. The limit of determination (LOD) was 5 μg·L-1. Conclusion: The method is sensitive, specific and suitable for the separation and determination of related substances in WF-208.
-----参考文献：---------------------------------------------------------------------------------------
1 Shenyang Pharmaceutical University (沈阳药科大学). Oxadiazoles base piperazine derivatives and its use (噁二唑基哌嗪衍生物及其用途).China(中国). Invention patent (发明专利) 201010139255.8, 2010-08-18
2 ZHOU Ming-hao(周明昊),SU Lei(苏雷)RP-HPLC determination of related substances in galanthanuice hydrobromide(反相高效液相色谱法测定氢溴酸加兰他敏有关物质). Chin J Pharm Anal(药物分析杂志), 2008, 28(3) : 466
3 WANG San-long(王三龙),CAI Bing(蔡兵),CUI Cheng-bin(崔承彬),et al. Study on induction of apoptosis by girinimbine in HCT-15 cell in vitro(吉九里香碱体外诱导HCT-15细胞凋亡的研究). Chin J Pharm Anal(药物分析杂志),2008,28(2):176
4 CAO Lie-zhen(曹烈臻),FAN Qi(范琦),LIU Xue-hui(刘学辉),et al.Ion-pair RP-HPLC simultaneous determination in gradient elution mode of rizatriptan benzoate and its related substances(RP-HPLC离子对梯度洗脱法同时测定苯甲酸利扎曲普坦含量和有关物质). Chin J Pharm Anal(药物分析杂志),2011,31(2):274
5 XU Li-jia(徐丽佳), CHEN Xiao-hui(陈晓辉), BI Kai-shun(毕开顺), et al. Separation and content detemination of the related substances of imidol hydrochloride by RP-HPLC (盐酸艾咪朵尔相关物质的分离与含量测定). J Shenyang Pharm Univ (沈阳药科大学学报), 2010, 27(6): 210
6 ChP(中国药典). 2010. Vol Ⅱ(二部) : Appendix(附录)31
欢迎阅读《药物分析杂志》！您是该文第 1589位读者！
