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目的:建立测试复方磺胺甲噁唑片中磺胺甲噁唑和甲氧苄啶两组分含量的高效液相方法,并对此方法进行系统的方法学验证,以确保应用该方法测试的结果准确、可靠。方法:采用色谱柱:Agilent TC-C18柱(4.6×150 mm,5μm,Agilent,美国),流动相:乙腈-0.05mol/L磷酸二氢钾溶液(内含0.2%三乙胺)(20:80)(最后用磷酸调至PH4.8),检测波长为240nm。结果:磺胺甲噁唑和甲氧苄啶分别在100mg·L-1-500mg·L-1和20mg·L-1-100mg·L-1范围内线性关系良好,相关系数分别为0.9994和0.9991(n=5);两组分的精密度和重现性均为良好;加样回收率分别为100.54%和98.76%;供试品溶液室温放置8h,两组分均为稳定。结论:本研究所得方法操作简单、快速,专属性高、重现性好,可准确测定复方磺胺甲噁唑片中磺胺甲噁唑和甲氧苄啶两组分含量,用于复方磺胺甲噁唑片的质量控制。
OBJECTIVE: To establish a HPLC method for the determination of sulfamethoxazole and trimethoprim in compound sulfamethoxazole tablets. The method was validated systematically to ensure that the results of this method were accurate ,reliable. Methods: The mobile phase consisted of acetonitrile-0.05mol / L potassium dihydrogen phosphate solution (containing 0.2% triethylamine) (20: 80) (finally adjusted to PH4.8 with phosphoric acid), the detection wavelength was 240nm. RESULTS: Sulfamethoxazole and trimethoprim had good linearity in the range of 100 mg · L-1-500 mg · L-1 and 20 mg · L-1-100 mg · L-1 respectively with the correlation coefficients of 0.9994 and 0.9991 ( n = 5). The precision and reproducibility of the two components were good. The recoveries were 100.54% and 98.76%, respectively. The samples were stable at room temperature for 8h. Conclusion: The method obtained in this study is simple, rapid, specific and reproducible. It can accurately determine the contents of both sulfamethoxazole and trimethoprim in compound sulfamethoxazole tablets, Quality control of azole tablets.