HPLC法同时测定复方磺胺间甲氧嘧啶钠粉中磺胺间甲氧嘧啶钠和甲氧苄啶的含量

Simultaneous Determination of Sulfamonomethoxine Sodium and Trimethoprim in Compound Sulfamonomethoxine Powder by HPLC

为建立同时测定复方磺胺间甲氧嘧啶钠粉中磺胺间甲氧嘧啶钠和甲氧苄啶的高效液相色谱方法,采用ECOSIL 120-5-C18(250 mm×4.6 mm,5.0μm)色谱柱,以乙腈-0.1%磷酸溶液(20∶80,V/V)为流动相进行洗脱,流速1.0 mL/min,检测波长270 nm,柱温30℃,进样量为20μL。结果表明,磺胺间甲氧嘧啶钠和甲氧苄啶色谱峰峰型良好,均能达到完全分离。磺胺间甲氧嘧啶和甲氧苄啶分别在0.10077~100.77μg/mL和0.10036~100.36μg/mL范围内线性关系良好(R^2>0.999)。精密度和稳定性等考察结果的相对标准偏差(RSD)均小于2.0%;而磺胺间甲氧嘧啶和甲氧苄啶的平均加样回收率分别为98.68%~100.01%和98.84%~99.94%,RSD也均小于2.0%,均符合方法学要求。采用建立的高效液相色谱法测定了5份供试品中磺胺间甲氧嘧啶钠和甲氧苄啶的含量,结果均符合规定,且与原质量标准方法的测定结果无显著性差异。建立的高效液相色谱法能够用于定量测定磺胺间甲氧嘧啶钠和甲氧苄啶的含量。

The aim of this study was to establish a HPLC method for simultaneous determination of the content of sulfamonomethoxine sodium and trimethoprim in compound sulfamonomethoxine sodium powder.The elution was performed by using ECOSIL 120-5-C18(250 mm×4.6 mm,5.0μm)column and using acetonitrile-0.1%H3PO4 solution(20∶80,V/V)as mobile phase.The flow rate was set at 1.0 mL/min.The detection wavelength was 270 nm.The column temperature was 30℃and the injection volume was 20μL.The results showed that sulfamonomethoxine and trimethoprim could be separated completely and the linear relationship of was good(R^2>0.999)in the range of(0.10077~100.77)μg/mL and(0.10036~100.36)μg/mL,respectively.The RSDs of precision and stability were less than 2.0%.The average recoveries of sulfamonomethoxine and trimethoprim were 98.68%~100.01%and 98.84%~99.94%,and the RSDs were less than 2.0%.All of them were in accordance with the requirements of the methodology.The relative contents of sulfamonomethoxine sodium and trimethoprim in 5 samples were in accordance with the requirements.No significance could be observed between the results detected by the established method and the standard method,which indicated that the established HPLC method could quantitatively determine the content of sulfamonomethoxine sodium and trimethoprim.