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 the content of sulfamethoxydiazine sodium and trimethoprim by HPLC

关键词:  磺胺间甲氧嘧啶钠  甲氧苄啶  高效液相色谱法  含量测定

Key words:  Sulfamethoxydiazine sodium  Trimethoprim  HPLC  Content determination

摘要:

为了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，试验采用了ECOSIL 120-5-C18（250 mm×4.6 mm，5.0 μm）色谱柱，以乙腈-0.1％磷酸溶液（20：80，V/V）为流动相进行洗脱，流速为1.0 mL/min，检测波长为270 nm，柱温为30℃，进样量为20 μL。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；且在0.5～80 μg/mL范围内线性关系良好（R2>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％；而平均加样回收率均在98％～102％之间，RSD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。

Abstract:

The aim of this study was to establish a HPLC method for simultaneous determination of the contenet of sulfamethoxydiazine sodium and trimethoprim in compound sulfamethoxydiazine sodium powder. The elution was performed by using ECOSIL 120-5-C18（250 mm×4.6 mm，5.0 μm）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 20 μL. The results showed that the chromatographic peak shape of sulfamethoxydiazine and trimethoprim was good and could be separated completely. The linear relationship was good (R2>0.999) in the range of 0.5～80 μg/mL. the relative standard deviation (RSD) of precision and stability were less than 2.0%. The average recovery of sulfamethoxydiazine and trimethoprim was about 98％～102％ and all the RSD were less than 2.0％. All of them were in accordance with the requirements of the methodology. The relative contents of sulfamethoxydiazine sodium and trimethoprim in 5 samples of compound sulfamethoxydiazine sodium powder were in accordance with the requirements. No significance could be observed between the results detected by the established method and the standard quality method, which indicated that the established HPLC method could quantitatively determine the content of sulfamethoxydiazine sodium and trimethoprim.