Determination of three components in compound clorprenaline tablet by capillary zone electrophoresis
Zou Ding
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(Zou D),Wu Xuejun(Wu XJ),Nan Guozhu(Nan GZ
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文章历史+
收稿日期
出版日期
1997-02-05
1998-06-05
发布日期
1998-06-05
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.
Zou Ding.
Determination of three components in compound clorprenaline tablet by capillary zone electrophoresis [J]. Chinese Pharmaceutical Journal, 1998, 33(06): 360-362