HPLC法同时测定小儿磺胺甘草合剂中两组分含量

Simultaneous Determination of Two Components in Sulfa-glycyrrhiza Mixture for Infant by HPLC

目的:建立测定小儿磺胺甘草合剂中磺胺嘧啶及磺胺二甲嘧啶含量的方法。方法:采用高效液相色谱法,色谱柱为DiamonsilC_(18)(250 mm×4.6 mm,5μm),流动相:甲醇-0.02 mol·L^(-1)磷酸二氢钾(用磷酸调节pH至3.5)(30:70),流速:0.9ml·min^(-1),检测波长:265 nm,柱温:40℃,进样量:10μl。结果:磺胺嘧啶和磺胺二甲嘧啶分别在6.03～60.32μg·ml^(-1)和6.91～69.12μg·ml^(-1)范围内线性关系良好;磺胺嘧啶的平均回收率为99.3%(RSD=0.63%),磺胺二甲嘧啶的平均回收率为99.4%(RSD=0.22%)。结论:该方法快速、结果准确可靠,适用于小儿磺胺甘草合剂的含量测定。

Objective： To determine the content of sulfadiazine and sulfamethazine in sulfa-glycyrrhiza mixture for infant, and establish an analytical method for this preparation. Method： HPLC was applied, the column was Diamonsil C18 （250 mm × 4. 6 mm,5μm）, the mobile phase was methanol- 0.02 mol. L-1 potassium dihydrogen phosphate （ adjust pH to 3.5 by phosphoric acid） （30： 70）, the flow rate was 0. 9 ml. min- 1, the UV detecting wavelength was at 265 nm, the column temperature was 40 ℃ and the sample size was 10 μl. Result： The linear relationship was fairly good when the concentration of sulfadiazine was within the range of 6.03-60. 32 μg . ml-1 and sulfamethazine was within the range of 6. 91-69. 12 μg.ml-1. The average recovery of sulfadiazine was 99.27% （RSD = 0. 63% ）, and Sulfamethazine was 99.43% （RSD --0.22% ）, respectively. Conclusion： This method is proved to be rapid, accurate and reliable. It is suitable for the quality control of sulfa-glycyrrhiza mixture for infant.