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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(capilaryzoneelectrophoresis,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
OBJECTIVE: To establish a precise and rapid method for the determination of chlorpromazine hydrochloride, dechlorhexine hydrochloride and bromhexine hydrochloride in compound chlorpromazine tablets. Methods: Capillary zone electrophoresis (CZE) was used with 0.05mol·L-1 (pH3.0) phosphate buffer as working solution to separate voltage of 18kV (operating current 100μA ~ 110μA). Results: The three components were completely separated from baseline within 8min ~ 15min. The concentration of each component was in the range of 40μg · ml-1 ~ 240μg · ml-1, and the concentration and peak area showed a good linear relationship. Trimethoprim (TMP) was selected as the internal standard to accurately determine the contents of three components, all within less than 1.2% (n = 9). The recoveries of three components were not low At 99.5%, RSD was less than 1.1% (n = 5). Conclusion: CZE compound chlorpromatin tablets content determination of three components, accurate and reliable, easy and easy, and the drug standard methods can only be qualitative, can not be determined