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目的:研究和寻找精密而简便地测定增效联磺片中磺胺甲唑、磺胺嘧啶及甲氧苄氨嘧啶3种成分含量的方法。方法:采用毛细管区带电泳法,以0.05mol·L-1磷酸盐缓冲液(pH=6.0)作运行液,恒定电压20kV(运行电流95μA~105μA),并与药品标准规定的方法相比较。结果:3种成分在3min~8min之内完全达到基线分离,各组分溶液浓度在70μg·ml-1~750μg·ml-1范围内,浓度与峰面积之间呈良好的线性关系。选用乙酰苯胺作内标物,可测定3种成分的含量,批内RSD均小于1%(n=9),3种成分的加样回收率不低于96.45%,RSD均小于3%(n=12)。结论:结果表明毛细管区带电泳(CZE)法准确可靠,方便易行,可进行增效联磺片中3种成分的含量测定,而药品标准中规定的方法只能测定两种磺胺药的总量和甲氧苄氨嘧啶的含量。
OBJECTIVE: To study and find a precise and simple method for the determination of sulfamethoxazole, sulfadiazine and trimethoprim-sulfamethoxazole (Sulfamethoxazole, Sulfadiazine and trimethoprim) in SXLS tablets. Methods: The capillary zone electrophoresis was carried out using 0.05mol·L-1 phosphate buffer solution (pH = 6.0) as the running solution and a constant voltage of 20kV (operating current 95μA ~ 105μA) Compared. Results: The three components were completely separated from baseline within 3min ~ 8min. The concentration of each component was in the range of 70μg · ml-1 ~ 750μg · ml-1, and the concentration and peak area showed a good linear relationship. Acetanilide was used as the internal standard to determine the content of three components, the intra-assay RSD was less than 1% (n = 9), the three components of the sample recovery rate of not less than 96.45%, RSD were less than 3% (N = 12). Conclusion: The results show that the capillary zone electrophoresis (CZE) method is accurate and reliable, convenient and easy to carry out the determination of the content of three components in synergistic disulfide tablets. However, the method prescribed in the drug standards can only determine the total amount of two sulfonamides Quantity and trimethoprim content.