[1]管海燕,李卓恒,于彩平,等.HPLC法测定盐酸贝那替秦原料药及其注射剂的含量和有关物质[J].陆军军医大学学报(原第三军医大学学报),2013,35(23):2542-2546.
　Guan Haiyan,Li Zhuoheng,Yu Caiping,et al.HPLC determination of benactyzine hydrochloride and related substances in the injection[J].J Amry Med Univ (J Third Mil Med Univ),2013,35(23):2542-2546.
点击复制

HPLC法测定盐酸贝那替秦原料药及其注射剂的含量和有关物质(/HTML )
分享到：

陆军军医大学学报（原第三军医大学学报）[ISSN:1000-5404/CN:51-1095/R]

卷:
35卷
期数:
2013年第23期
页码:
2542-2546
栏目:
论著
出版日期:
2013-12-15

文章信息/Info

Title:
HPLC determination of benactyzine hydrochloride and related substances in the injection
作者:
管海燕; 李卓恒; 于彩平; 金竹; 卢来春
第三军医大学大坪医院野战外科研究所药剂科
Author(s):
Guan Haiyan;  Li Zhuoheng;  Yu Caiping;  Jin Zhu;  Lu Laichun
Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, China
关键词:
盐酸贝那替秦; 含量测定; 有关物质; HPLC
Keywords:
benactyzine hydrochloride;  content determination; related substance;  high performance liquid chromatography
分类号:
R927.2; R944.11; R971.92
文献标志码:
A
摘要:
目的      建立HPLC测定盐酸贝那替秦原料药及其注射剂的含量和有关物质的方法。      方法       以乙腈-磷酸二氢钾溶液（每1 000毫升含6.80 g磷酸二氢钾、0.556 g庚烷磺酸钠）35∶65为流动相；采用反相C18色谱柱，以1.0 mL/min流速，210 nm检测波长，30 ℃柱温，20 μL进样量为色谱条件进行测定。      结果       盐酸贝那替秦原料药及注射液中各杂质峰峰面积之和不超过对照溶液主峰面积的1%；盐酸贝那替秦在浓度1～200 μg/mL范围内具有良好线性关系（r=0.999 5），高、中、低浓度的平均回收率分别为98.99%（RSD=0.67%）、99.96%（RSD=0.10%）、101.21%（RSD=0.11%）；日内（n=3）及日间精密度（n=5）RSD均小于2%，定量限1.7 ng，检测限0.4 ng。      结论       本实验方法专属性强、准确度高，可用于盐酸贝那替秦原料药和注射液的质量控制。
Abstract:
Objective      To develop a high performance liquid chromatography (HPLC) method for detecting benactyzine hydrochloride and its related substances in the injection.       Methods      HPLC was performed to detect benactyzine and its related substances under the wave length of 210 nm under 30 ℃. The chromatographic conditions were as follow: the mixed solvent of acetonitrile and buffer of potassium dihydrogen phosphate (each 1 000 mL containing 6.80 g of potassium dihydrogen phosphate, 0.556 g sodium heptanesulfonate) (35∶65) was used as mobile phase, flow rate was 1 mL/min, injection volume was 20 μL.       Results      The total peak areas of related substances did not exceed 1% of the main peak area of reference solution. The linear ranges of benactyzine hydrochloride were 1 to 200 μg/mL (r=0.999 5). The average recoveries of high, medium and low concentrations were 98.99%（RSD=0.67%）, 99.96%（RSD=0.10%）, and 101.21%（RSD=0.11%）respectively. The RSD of intra-day (n=3) and inter-day assay (n= 5) were less than 2%. The limit of quantitation was 1.7 ng, and the limit of detection was 0.4 ng.       Conclusion      Our HPLC method is proved to be highly selective, accurate and suitable for the quality control of benactyzine hydrochloride injection.

相似文献/References:

[1]孙燕.HPLC法测定活络镇痛胶囊中欧前胡素的含量[J].陆军军医大学学报(原第三军医大学学报),2012,34(16):1694.
[2]来小丹,刘松青,黄华,等.氟比洛芬口腔崩解片的制备及质量控制[J].陆军军医大学学报(原第三军医大学学报),2008,30(09):837.
　LAI Xiao-dan,LIU Song-qing,HUANG Hua,et al.Preparation and quality control of flurbiprofen orally disintegrating tablets[J].J Amry Med Univ (J Third Mil Med Univ),2008,30(23):837.
[3]应懿,何志红,周世文,等.测定黄连中5种生物碱含量的高效液相色谱法研究[J].陆军军医大学学报(原第三军医大学学报),2007,29(09):843.
　YING Yi,HE Zhi-hong,ZHOU Shi-wen,et al.Determination of the alkaloids in Rhizoma Coptidis by HPLC[J].J Amry Med Univ (J Third Mil Med Univ),2007,29(23):843.
[4]李标,杨秀丽,蒲道俊,等.HPLC法测定复方阿司匹林双层片的含量[J].陆军军医大学学报(原第三军医大学学报),2009,31(08):759.
[5]张蓉,卢来春,邢茂.人工神经网络紫外光谱法测定复方氧氟沙星滴耳液的药物含量[J].陆军军医大学学报(原第三军医大学学报),2005,27(03):266.
[6]李国成,刘春霞,余晓霞.微晶纤维素的含量测定[J].陆军军医大学学报(原第三军医大学学报),2009,31(19):1914.
[7]胡大强,卢华,管海燕,等.辐照对去甲肾上腺素注射液含量变化的影响[J].陆军军医大学学报(原第三军医大学学报),2012,34(05):431.
　Hu Daqiang,Lu Hua,Guan Haiyan,et al.Effect of irradiation on content of Norepinephrine Bitartrate Injection[J].J Amry Med Univ (J Third Mil Med Univ),2012,34(23):431.
[8]赵德华,卢来春,管海燕,等.牛蒡子苷自微乳在体肠吸收分析方法学研究[J].陆军军医大学学报(原第三军医大学学报),2013,35(24 ):2681.
　Zhao Dehua,Lu Laichun,Guan Haiyan,et al.Analytical methodology on in situ rat intestine absorption of arctiin SMEDDS[J].J Amry Med Univ (J Third Mil Med Univ),2013,35(23):2681.
[9]李蔚,朱捷,张妍.注射用头孢噻吩钠含量测定及与3种大输液的配伍稳定性分析[J].陆军军医大学学报(原第三军医大学学报),2011,33(12):1313.
[10]杨万兴.补益口服液中人参皂苷Rg1的含量测定方法[J].陆军军医大学学报(原第三军医大学学报),2003,25(24):0.[doi:10.16016/j.1000-5404.2003.24.033 ]

更新日期/Last Update: 2013-12-06