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目的:建立测定吉法酯片含量的分析方法。方法:高效液相色谱-蒸发光散射检测(HPLC-ELSD)法,色谱柱为Agi-lent ZORBAX SB-C18色谱柱(150mm×4.6mm,5μm);流动相为甲醇-乙腈(55∶45),流速1.0mL.min-1,柱温:30℃,蒸发光检测器(以空气为载气,流速2L.min-1,漂移管温度70℃)检测。结果:吉法酯质量线性范围0.416～2.080μg,r=0.9996;平均回收率为99.8%(n=9),检出限(S/N=3)为8.32ng。6个批次吉法酯片含量为11.53%～11.63%。结论:该法操作简便,灵敏度高,重复性好,是吉法酯片含量测定的有效方法。
Objective: To establish a method for the determination of jifa ester tablets. Methods: The HPLC-ELSD method was used. The column was Agi-lent ZORBAX SB-C18 column (150 mm × 4.6 mm, 5 μm). The mobile phase was methanol-acetonitrile (55:45) , The flow rate of 1.0mL.min-1, column temperature: 30 ℃, evaporating detector (air as carrier gas, flow rate 2L.min-1, drift tube temperature 70 ℃) detection. Results: The linear range of JGF was 0.416 ~ 2.080μg, r = 0.9996. The average recovery was 99.8% (n = 9). The detection limit (S / N = 3) was 8.32ng. 6 batches of jifa ester content of 11.53% ~ 11.63%. Conclusion: The method is simple, sensitive and reproducible. It is an effective method for the determination of jifa-ester tablets.