摘要
目的:考查不同试验条件下氯喹那多及有关物质的液相色谱行为,建立氯喹那多有关物质及含量的HPLC测定方法。方法:C_(18)柱(250 mm×4.6 mm,填料:Hypersil,粒度:5 μm),用甲醇-水-磷酸(85:15:0.5)为流动相,检测波长251nm。结果:氯喹那多在12—140μg·mL^(-1)范围内与峰面积呈良好的线性关系,且操作简便,可同时进行含量和有关物质的测定,线性关系r=0.9999,重复性试验RSD为0.33%(n=5);3批样品平均回收率分别为99.97%,99.94%和99.96%,该方法已应用于样品的测定。结论:此法简单,结果准确可靠,可用于氯喹那多的质量控制。
Objective: To establish HPLC method for determination of content of chlorquinaldol and its related substances. Methods: Dikma-C_(18) column (250 mm×4. 6 mm, Hypersil, 5μm)with methanol-water-phosphoric acid(85: 15:0. 5) as mobile phase. The flow rate was 1 mL·min^(-1),the ultraviolet detection wavelength was 251 nm. Results:There was a good linar relationship within the range of 12-140μg·mL^(-1) (r=0.9999). The method was validated, and the stability tests under various conditions were performed. The reproducibility and precision of method were good(RSD=0. 33%). Conclusion; The method proposed for content determination of chlorquinaldol and its related substances by HPLC is simple, accurate, specific and could be used in quality control chlorquinaldol.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第3期314-316,共3页
Chinese Journal of Pharmaceutical Analysis