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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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反相高效液相色谱法测定甲泼尼龙琥珀酸钠注射液含量和有关物质

RP-HPLC determination of methylpredisolone sodium succinate injection and its related substances

分类号:
出版年·卷·期(页码):2012,32 (6):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立甲泼尼龙琥珀酸钠注射液含量以及有关物质的反相高效液相色谱检测方法。 方法: 采用Zorbax-XDB-C18柱(100 mm×46.mm,5 μm),流动相为0.66%四丁基氢氧化铵溶液(磷酸调pH至6.5)-乙腈(3∶2),流速1.0 mL·min-1,检测波长为254 nm。 结果: 甲泼尼龙琥珀酸在100~900 μg·mL-1浓度范围内线性关系良好(r=1.0000),高、中、低3种不同浓度的回收率分别为100.7%,100.5%,100.7%,定量限0.5 μg·mL-1,游离甲泼尼龙在10-50 μg·mL-1浓度范围内线性关系良好(r=1.0000),高、中、低3种不同浓度回收率分别为100.5%,100.6%,100.3%,检测限0.05 μg·mL-1结论: 本方法将现有的正相色谱法改进为反相色谱法。操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish an RP-HPLC method for determination of methylpredisolone succinate injection and its related substunces. Method: Zorbax-XDB-C18 column(100 mm×4.6 mm,5 μm) was used.Mobile phase was 0.66% tetrabutylammonium hydroxide solution(pH was adjusted to 6.5 by phosphoric acid)-acetonitrile(3∶2),the flow rate was 1.0 mL·min-1and the detection wavelength was 254 nm. Results: Calibration curve of methylpredisolone succinate was linear range of 100-900 μg·mL-1(r=1.00000),and the average recoveries of its high,middle and low concentrations were 100.7%,100.5% and 100.7%,respectively.Calibration curve of methylpredisolone was linear range of 10-50 μg·mL-1(r=0.99995),and the average recoveries of its high,middle and low concentrations were 100.5%,100.6% and 100.3%,respectively. Conclusions: The RP-HPLC method is employed instead of the former NP-HPLC.This method is accurate and reliable,so it can be used for quality control of methylpredisolone sodium succinate injection.

-----参考文献:---------------------------------------------------------------------------------------
1 ZHANG XIANG-ming(张祥民).Modern Chromatograhy Analysis(现代色谱分析).Shanghai(上海):Fudan Press(复旦大学出版社),2006.75
2 XU Fan(徐帆),FENG EN-fu(冯恩富),ZHAO Zheng-ying(赵正英).Stability of doxofylline injection,nikethamide injection,lobeline injection and methylprednisolone sodium succinate for injection in compatibility solutions(多索茶碱、洛贝林、尼克刹米、甲泼尼龙琥珀酸钠注射剂配伍稳定性研究).China Pharm(中国药师),2008,11(3):120
3 ZHANG Ying(张莹),BAI Hai-jiao(白海娇),LI Hai-sheng(李海生).HPLC determination of related substances in hydrocortisone sodium succinate for injection(HPLC法测定注射用氢化可的松琥珀酸钠中的有关物质).Chin J Pharm Anal(药物分析杂志),2007,27(4):607
4 YIN Qin-hong(殷勤红),ZHU Yan-Qin(朱艳琴),FENG Pu-Chun(冯朴纯).Chromatogram conditions for determination of hydrocortisone sodium succinate for injection by HPLC(高效液相色谱法测定注射用氢化可的松琥珀酸钠含量的色谱条件考察).Chin J Spectrosc Lab(光谱实验室),2010,6(27):2246
5 HU Hong-wen(胡宏纹).Organic Chemistry(有机化学).Beijing(北京):High Education Press(高等教育出版社),1979.434
6 SUN YU-qing(孙毓庆),HU YU-zhu(胡育筑).Selection and Optimization of LC Solution System(液相色谱溶剂系统的选择和优化).Beijing(北京):Chemical Industry Press(化学工业出版社),2007.43

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