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目的建立亲水作用色谱-蒸发光散射检测器联法(HILIC-ELSD)测定妥布霉素滴眼液中氯离子含量的方法。方法采用ZIC?-HILIC亲水作用色谱柱(硅胶基质的两性离子柱)进行分离,以乙腈∶50 mmol·L~(-1)乙酸铵溶液(70∶30)为流动相,流速为1.0 mL·min~(-1),柱温为35℃,以Waters 2424 ELSD检测,漂移管温度90℃,喷雾加热50%,载气压力为30 psi,信号增益为50。结果妥布霉素滴眼液中的氯离子在84.96~339.83μg·mL~(-1)(r=0.999 3)范围内呈良好的线性关系,其平均回收率为98.18%,RSD为0.75%(n=6)。结论该方法简便、准确度高、灵敏度高且具有良好的重现性,可用于药物制剂中氯离子的含量测定。
Objective To establish a method for determination of chloride ion in tobramycin eye drops by hydrophilic interaction chromatography coupled with evaporative light scattering detector (HILIC-ELSD). Methods The separation was performed on a ZIC-HILIC hydrophilic column (zwitterionic column on silica gel). The mobile phase consisted of acetonitrile: 50 mmol·L -1 ammonium acetate solution (70:30) and the flow rate was 1.0 mL · Min ~ (-1). The column temperature was 35 ℃ and was detected by Waters 2424 ELSD. The drift tube temperature was 90 ℃, the spray was heated 50%, the carrier gas pressure was 30 psi and the signal gain was 50. Results Tobamycin eye drops showed a good linearity in the range of 84.96 ~ 339.83μg · mL -1 (r = 0.999 3) with an average recovery of 98.18% and a RSD of 0.75% (n = 6). Conclusion The method is simple, accurate, sensitive and reproducible. It can be used for the determination of chloride ion in pharmaceutical preparations.