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目的建立高效液相色谱法测定非甾体抗炎镇痛化合物4-邻甲苯磺酰氧基苯并噁唑酮(MBB)原料药的含量及有关物质。方法采用Odyssil C18(150 mm×4.6 mm,5μm)色谱柱,以甲醇-水(65∶35)为流动相,流速为0.8 mL.min 1,检测波长为273 nm,柱温为25℃。结果供试品中主成分峰与各杂质峰分离良好,MBB的线性范围为1～150μg.mL 1,回归方程为A=3 959.8C 2 831(r=0.999 7),平均回收率为99.2%(RSD=1.1%,n=9),检测限为1 ng。结论本方法简便、准确、专属性好,可用于MBB原料药的含量测定及有关物质检查。
OBJECTIVE To establish a HPLC method for the determination of 4-o-tosyloxybenzoxazolone (MBB) as a non-steroidal anti-inflammatory analgesic drug and its related substances. Methods The chromatographic column was Odyssil C18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol and water (65:35) with a flow rate of 0.8 mL.min 1. The detection wavelength was 273 nm and the column temperature was 25 ℃. The results showed that the main component peak and the impurity peak in the test sample were well separated. The linear range of MBB was 1 ~ 150μg.mL 1, the regression equation was A = 9595.8C 2 831 (r = 0.999 7), the average recovery was 99.2% (RSD = 1.1%, n = 9) with a detection limit of 1 ng. Conclusion The method is simple, accurate and specific, and can be used for the determination of MBB drug substance and related substances.