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建立反相高效液相色谱法测定格列齐特中对甲苯磺酰胺的含量。方法:采用奥泰公司C8色谱柱(220mm×4.6mm,5μm),甲醇-乙腈-水(10:10∶80)为流动相,检测波长为268nm,流速为1.0ml/min,柱温为30℃。对甲苯磺酰胺在0.5~2.0μg·m L-1范围内呈良好的线性关系(r=0.99995)。对甲苯磺酰胺平均回收率分别为99.3%。结论:本法简便、准确,可用于格列齐特中对甲苯磺酰胺的含量测定。
To establish an RP-HPLC method for the determination of p-toluenesulfonamide in gliclazide. Methods: The chromatographic column (220mm × 4.6mm, 5μm) and methanol-acetonitrile-water (10: 10:80) were used as the mobile phase. The detection wavelength was 268nm, the flow rate was 1.0ml / ℃. Toluene sulfonamide showed a good linearity (r = 0.99995) in the range of 0.5 ~ 2.0μg · m L-1. The average recovery of p-toluenesulfonamide was 99.3%. Conclusion: This method is simple, accurate and can be used for the determination of p-toluenesulfonamide in gliclazide.