盐酸克仑特罗片剂中克仑特罗及其杂质含量的HPLC测定
DETERMINATION OF CLENBUTEROL HYDROCHLORIDE AND IMPURITIES IN TABLETS BY HPLC
摘 要
建立了测定盐酸克仑特罗片剂含量的高效液相色谱法.选用Agilent Eclipse XDB-C8柱 (4.6 mm×250 mm,5 μm),流动相为甲醇-水(40∶60,含20 mmol·L-1磷酸二氢钾,以磷酸调至pH 4.0),流速为1.0 mL·min-1,检测波长240 nm,线性范围为0.50-50.0 mg·L-1(r=0999 9),检出限为0.5 ng,回收率在98.5-102.0%之间,RSD为2.06%-3.07%(n=5).
盐酸克仑特罗片剂
含量
杂质
HPLC
Clenbuterol hydrochloride tablets
Content
Impurities
Abstract
In the HPLC determination of clenbuterol hydrochloride in its tablets,agilent eclipse XDB-C8 column (4.6 mm×250 mm,5 μm) and mobile phase of methanol-water (40∶60) mixture,containing 20 mmol·L-1 KH2PO4 adjusted to pH 4.0 with H3PO4 (2+998) were used.The flow-rate of the sample solution of 1.0 mL per min,and the UV detection at 240 nm were taken.Range of linearity of the method was found in the range of 050-50.0 mg·L-1 of clenbuterol (r=0.999 9),with a detection limit of 0.5 ng.In the analysis of samples of clenbuterol hydrochloride tablets of known contents,RSD′s (n=5) obtained were in the range from 2.06% to 307%,and recoveries found by the standard addition method were in the range of 98.5%-102.0%.
中图分类号 O657.7
所属栏目 工作简报
基金项目 浙江省分析测试基金资助项目(04083)
收稿日期 2006/3/5
修改稿日期
网络出版日期
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备注李立(1958-),女,福建泉州人,副教授,从事分析测试技术研究工作.
引用该论文: LI Li,LI Cheng-ping. DETERMINATION OF CLENBUTEROL HYDROCHLORIDE AND IMPURITIES IN TABLETS BY HPLC[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2006, 42(6): 432～434
李立,李成平. 盐酸克仑特罗片剂中克仑特罗及其杂质含量的HPLC测定[J]. 理化检验－化学分册, 2006, 42(6): 432～434
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参考文献
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【6】Bazylak G,Nagels L J.Simultaneous High-Throughput Determination of Clenbuterol,Ambroxol and Bromhexine in Pharmaceutical Formulations by HPLC with Potentiometric Detection[J].Journal of Pharmaceutical & Biomedical Analysis,2003,32(4/5):887-903.
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【3】王树槐,刘 琪.高效液相色谱/质谱联用仪测定盐酸克仑特罗[J].中国兽药杂志,2002,36(3):36-37.
【4】Joyce C,Smyth W F,Ramachandran V N,et al.The Characterisation of Selected Drugs with Amine-Containing Side Chains Using Electrospray Ionisation and ion Trap Mass Spectrometry and Their Determination by HPLC-ESI-MS[J].Journal of Pharmaceutical & Biomedical Analysis,2004,36(3):465-476.
【5】García I,Sarabia L,Cruz O M,et al.Three-Way Models and Detection Capability of a Gas Chromatography-Mass Spectrometry Method for the Determination of Clenbuterol in Several Biological Matrices: the 2002/657/EC European Decision[J].Analy Chim Acta,2004,515(1):55-63.
【6】Bazylak G,Nagels L J.Simultaneous High-Throughput Determination of Clenbuterol,Ambroxol and Bromhexine in Pharmaceutical Formulations by HPLC with Potentiometric Detection[J].Journal of Pharmaceutical & Biomedical Analysis,2003,32(4/5):887-903.
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