摘要
目的:建立精密、快速简便地测定复方氯丙那林片中盐酸氯丙那林、盐酸去氯羟嗪及盐酸溴己新3种成分含量的方法。方法:采用毛细管区带电泳法(capilary zone electrophoresis,CZE),以0.05mol·L-1(pH3.0)磷酸盐缓冲液作运行液,分离电压18kV(运行电流100μA~110μA)。结果:3种成分在8min~15min之内完全达到基线分离,各组分溶液浓度在40μg·ml-1~240μg·ml-1范围内,浓度与峰面积之间呈良好的线性关系。选用甲氧苄氨嘧啶(TMP)作内标物,可准确测定3种成分的含量,批内(RSD)均小于1.2%(n=9),3种成分的加样回收率不低于99.5%,RSD均小于1.1%(n=5)。结论:用CZE进行复方氯丙那林片中3种成分的含量测定,准确可靠、方便易行,而药品标准中规定的方法只能定性,不能进行含量测定。
Abstract
OBJECTIVE: To study a method for determination of three components, clorprenaline hydrocloride, bromhexine hydrocloride and decloxizine hydroxloride in compound clorprenaline tablet. METHOD: A capillary zone electrophoresis (CZE) method was used to assay three components of this compound preparation. The complete separation of components was achieved with 0.05 mol·L-1 pH 3.0 running phosphate buffer and a constant voltage of 18 kV (current of 100 μA~110 μA). RESULTS: The retention times of individual components were between eight and fifteen minutes and a good linearity was shown between concentrations and peak areas in the concentration range over 40 μg·ml-1~240 μg·ml -1 . Using trimethoprim as internal standard. The relative standard deviation (RSD) of each component determined in a batch was less than 1.2% (n=9). The recovery of each component was not less than 99.5% with RSD less than 1.1% (n=5). CONCLUSION: This method is accurate, simple and rapid. The quantity of each three components may be determined using this method. The three components were only identified by the standard method.
关键词
毛细管区带电泳 /
氯丙那林 /
去氯羟嗪
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Key words
capillary zone electrophoresis /
clorprenaline /
decloxizine /
bromhexine
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邹定;吴学军;南国柱.
毛细管区带电泳测定复方氯丙那林片中3种药物含量[J]. 中国药学杂志, 1998, 33(06): 360-362
Zou Ding.
Determination of three components in compound clorprenaline tablet by capillary zone electrophoresis [J]. Chinese Pharmaceutical Journal, 1998, 33(06): 360-362
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参考文献
1 上海市药品标准(上册).1980:241.
2 王生华,唐树荣.差示光谱法测定复方氯喘片中盐酸去氯羟嗪,药物分析杂志,1989,9(5):307.
3 陈波,唐树荣.高效液相色谱法测定复方氯喘片中盐酸去氯羟嗪和盐酸溴己新的含量.药物分析杂志,1993.13(4):241.
4 邹定,吴学军,南国柱.去痛片(索密痛)的胶束动电毛细管色谱测定.药物分析杂志,1996,16(2):92.
5 姜文清,马捷,郭郁.胶束动电毛细管色谱法测定含β-内酰胺酶抑制剂的青霉素药物.药物分析杂志,1995,15(增刊):72.
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脚注
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