HPLC-ELSD测定妥布霉素滴眼液的含量

Determination of Tobramycin Eye Drops by HPLC-ELSD

关键词:  妥布霉素  滴眼液  含量测定  高效液相色谱法  蒸发光散射检测器

Key words:  tobramycin  eye drops  content determination  HPLC  ELSD

摘要:

目的建立高效液相色谱-蒸发光散射检测器检测法(HPLC-ELSD)测定妥布霉素滴眼液的含量。方法选用耐酸性的Agilent Zorbax SB-C18(4.6 mm×250mm，5 μm)色谱柱；流动相为0.2 mol·L-1三氟乙酸溶液-甲醇(92∶8)，柱温为35 ℃，流速为0.8 mL·min-1，进样体积为10 mL；ELSD检测器漂移管温度为45 ℃，雾化气体压力为3.5 bar，信号增益(GAIN)为5。结果妥布霉素在55.6～1 396.7 mg·mL-1内，其峰面积的对数与浓度的对数呈良好的线性关系(r = 0.999 7)，检测限和定量限分别为0.15 mg·mL-1和0.45 mg·mL-1。结论方法专属性强，准确可靠，适用于妥布霉素滴眼液产品质量控制。

Abstract:

OBJECTIVE To establish an HPLC - ELSD method for the content determination of tobramycin eye drops. METHODS In this method, the column was Agilent Zorbax SB - C18 (4.6 mm×250 mm, 5 mm); The mobile phase consisted of 0.2 mol·L-1 trifluoroacetatic acid solution-methanol (92∶8) at a flow rate of 0.8 mL·mL-1. The drift tube temperature was set at 45 ℃, and the pressure of nebulizing gas was 3.5 bar. RESULTS The linear range was 55.6-1396.7 μg·mL-1(r=0.999 7). The limit of detection and quantification was 0.15 μg·mL -1 and 0.45 μg·mL -1 respectively. An average recovery of 99.0% with a RSD of 1.05% (n=9) was obtained. The precision for content determination of tobramycin was good (RSD = 0.8%, n=9). CONCLUSION The method is simple, accurate and reliable. It is suitable for the routine quality control of tobramycin eye drops preparations.