酸性染料比色法测定盐酸埃他卡林片的含量、含量均匀度及其溶出度

孙建绪;张梅;高永良

中国药学杂志 ›› 2003, Vol. 38 ›› Issue (11) : 871-872.

中国药学杂志 ›› 2003, Vol. 38 ›› Issue (11) : 871-872.
药品质量及检验

酸性染料比色法测定盐酸埃他卡林片的含量、含量均匀度及其溶出度

  • 孙建绪;张梅;高永良
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Determination of content,uniformity and dissolution of Iptakallm Hydrochloride tablets by acid dye spectrophotometry

  • SUN Jian-xu1,ZHANG mei2,GAO Yong-liang1
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摘要

目的测定盐酸埃他卡林片的含量、含量均匀度及溶出度。方法采用溶剂萃取酸性染料比色法测定含量,检测波长412 nm。溶出度以桨法测定,转速50 r·min-1,溶出介质为250 mL 0.1 mol·L-1盐酸溶液。结果1.5~7.5 μg·mL-1内线性良好,r=0.999 9 (n=3),平均回收率100.2% (n=10),RSD为0.5657%。片剂10 min取样,主药溶出80%以上。结论方法简便、准确、专属性强。可作为该制剂的含量测定和质量控制方法。

Abstract

OBJECTIVE To determine the content and dissolution of Iptakallm Hydrochloride tablets (IHT). METHODS A solvent extractionacid dye spectrophotometry method was used with the detection wavelength at 412 nm.Paddle method was used to determine the dissolution.The rotation speed was 50 r·min-1 and the dissolution medium was 250 mL of 0.1 mol·L-1Hydrochloric acid solution. RESULTS The linear range of the standard curve was 1.5~7.5 μg·mL-1 (r=0.999 9,n=3).The average recovery of the assay was 100.2% with a relative standard deviation of 0.565 7% (n=10).The drug dissolution at 10 min was above 80%. CONCLUSION This method is convenient,accurate and specific for the quality control of IHT.

关键词

盐酸埃他卡林片 / 酸性染料比色法 / 含量测定

Key words

Iptakallm hydrochloride tablets / acid dye spectrophotometry / content determination / dissolution

引用本文

导出引用
孙建绪;张梅;高永良. 酸性染料比色法测定盐酸埃他卡林片的含量、含量均匀度及其溶出度[J]. 中国药学杂志, 2003, 38(11): 871-872
SUN Jin-xu;ZHNG mei;GO Yong-ling. Determination of content,uniformity and dissolution of Iptakallm Hydrochloride tablets by acid dye spectrophotometry[J]. Chinese Pharmaceutical Journal, 2003, 38(11): 871-872

参考文献

[1]刘蔚,龙超良,路新强,等.盐酸埃他卡林对大鼠离体工作心脏功能的影响[J].中国药理学通报,2002,18(3):349. [2]张振清,袁淑兰,乔建忠,等.GCMS测定体内盐酸埃他卡林及药代动力学研究[J].分析测试学报,2001,20(增刊Ⅰ):17.

基金

国家1035工程项目(No.969010101)

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