摘要
目的:针对中国药典2010年版二部盐酸麻黄碱有关物质项下的色谱条件提出修改建议。方法:采用Ultimate AQ-C18色谱柱(3.0 mm×250 mm,5μm),以磷酸盐缓冲溶液(取磷酸二氢钾6.8 g,加三乙胺5 m L,磷酸4 m L,加水至1 000 m L,用稀磷酸或三乙胺调节pH至3.0±0.1)-乙腈(96∶4)为流动相,流速1.0 m L·min-1,检测波长210 nm,进样量10μL。在优化后的色谱条件下,麻黄碱峰与伪麻黄碱峰之间的分离度为2.54,麻黄碱峰的理论塔板数为11 232。结果:按本文色谱条件及拟定的系统适用性要求对盐酸麻黄碱样品进行有关物质检查,均检测出盐酸伪麻黄碱,使检验结果更加准确可靠。结论:本方法经方法学验证,可为提高盐酸麻黄碱质量标准提供参考。
Objective ：To put forward modification proposals referring to the Chinese Pharmacopeia 2010 edition of ephedrine hydrochloride chromatographic conditions. Methods ：The test was performed on an Ultimate AQ-C18 col- umn （3.0 mm × 250 mm,5 μm） with the mobile phase consisted of phosphate buffer solution （ potassium dihydro- gen take 6.8 g, triethylamine 5 mL, phosphoric 4 mL, add water to 1 000 mL, with dilute phosphoric acid or triethyl- amine adjusted to pH 3.0 ±0. 1 ） -acetonitrile （96： 4） at a flow rate of 1.0 mL·min-l. The detection wavelength was 210 nm ,and the injection volume was 10 p,L. Under the optimized chromatographic conditions, the separation between ephedrine and pseudoephedrine peaks is 2.54. The theoretical plate number of ephedrine peak is 11 232. Results：According to the established chromatography conditions and the proposed system suitability requirements on material inspection of ephedrine hydrochloride samples, pseudoephedrine hydrochloride was detected at a more ac- curate and reliable state. Conclusion：The established method has been validated , which can provide a reference for the improvement of quality control of ephedrine hydrochloride.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2015年第7期1299-1304,共6页
Chinese Journal of Pharmaceutical Analysis
关键词
盐酸麻黄碱
盐酸伪麻黄碱
有关物质
色谱条件优化
检查方法
ephedrine hydrochloride
pseudoephedrine hydrochloride
related substances
optimization of the chroma-tographic conditions
inspection methods
