[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.
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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 )
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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 determinationrelated 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.

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更新日期/Last Update: 2013-12-06