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刊物信息

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@nifdc.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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HPLC法测定盐酸异丙嗪注射液的含量和有关物质___

HPLC determination of promethazine hydrochloride injection and its related substances

分类号:
出版年·卷·期(页码):2010,30 (4):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

 
 
目的:建立高效液相色谱法,测定盐酸异丙嗪注射液的含量和有关物质。方法:采用C18柱,以0.05 mol·L-1磷酸二氢铵(用磷酸调节pH至3.2)-乙腈(70∶30)为流动相,流速1.0 mL·min-1,检测波长249 nm。结果:盐酸异丙嗪浓度在10.13~121.58 μg·mL-1范围内呈良好的线性关系,r=0.9995;平均回收率为100.3%,RSD=0.33%(n=6);有关物质各杂质与主峰之间的分离度良好。检测限和定量限分别为0.4 ng和1.6 ng。结论:本法简便、准确,专属性好,灵敏度高。
 
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-----英文摘要:---------------------------------------------------------------------------------------

Objective:To develop an HPLC method for determination of promethazine hydrochloride and its related substances in injections.Method:Using HPLC with Diamonsil C18 column,0.05 mol·L-1 diammonium dihydrogen phosphate(adjusted to pH 3.2 with phosphoric acid)-acetonitrile (70∶30) as the mobile phase.The wavelength used for detection was 249 nm.Results:The standard curve was rectilinear in the range of 10.13-121.58 μg·mL-1 (r=0.9995).The average recovery was 100.3% (RSD=0.33%,n=6).Good separation of promethazine hydrochloride and its related substances could be achieved.The limit of detection and quantification were 0.4 ng and 1.6 ng.Conclusion:This method is simple,sensitive,selective and repetitive

-----参考文献:---------------------------------------------------------------------------------------
1ChP(中国药典)2005.Vol Ⅱ(二部):512
2CHEN Jian(陈建),LI Yun(利云),ZHANG Jia-ming(张家明).HPLC determination of reserpine and promethazine hydrochloride in compound capsules of antihypertension(HPLC法测定复方降压胶囊中利血平及盐酸异丙嗪含量).Chin J Pharm Anal(药物分析杂志),2008,28(7):1159
3LIANG Gai-ling(梁改玲),WANG Xue-qin(王雪芹),ZHONG Ping(仲平).HPLC determination of promethazine hydrochloride in promethazine and bile tablets(高效液相色谱法测定异丙嗪胆汁片中盐酸异丙嗪的含量).Chin J Pharm Anal(药物分析杂志),2005,25(9):1129
4WANG Li-na(王丽娜),LI Yan-jie(李艳杰).Simultaneous determination of chlordiazepoxide and promethazine hydrochloride in luojijiangya tablets by HPLC(HPLC法同时测定罗己降压片中氯氮草和盐酸异丙嗪的含量).Chin Pharm Aff(中国药事),2009,23(1):60
5LIANG Gai-ling(梁改玲),WANG Xue-qin(王雪芹),ZHONG Ping(仲平).HPLC determination of promethazine hydrochloride in promethazine and bile tablets(高效液相色谱法测定异丙嗪胆汁片中盐酸异丙嗪的含量).Chin J Pharm Anal(药物分析杂志),2005,25(9):1129
6CHEN Jian(陈建), LI Yun(利云), ZHANG Jia-ming(张家明),et al.HPLC determination of reserpine and promethazine hydrochloride in compound capsules of antihypertension(HPLC法测定复方降压胶囊中利血平及盐酸异丙嗪含量).Chin J Pharm Anal(药物分析杂志),2008,28(7):1168
 

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