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目的建立测定注射用盐酸头孢替安含量的反相高效液相色谱法。方法色谱柱为DiamonsilTMC18(4.6mm×250mm,5μm),流动相为乙腈-水(1.5%乙酸)(5∶95),流速1.0mL·min-1,检测波长254nm,柱温40℃。结果盐酸头孢替安浓度在12~2000mg·mL-1内,峰面积与浓度呈良好线性关系(r=0.9999),加样回收率为98.8%,RSD为1.35%(n=5)。结论该方法简便可靠,能够满足注射用盐酸头孢替安的含量测定要求。
Objective To establish a reversed-phase high performance liquid chromatography (HPLC) for the determination of cefotiam hydrochloride for injection. Methods The column was Diamonsil TMC18 (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile-water (5:95) with a flow rate of 1.0 mL · min-1. The detection wavelength was 254 nm and the column temperature was 40 ℃. Results The peak area was positively correlated with the concentration of cefotiam hydrochloride (r = 0.9999). The average recoveries were 98.8% with a RSD of 1.35% (n = 5). Conclusion The method is simple and reliable, and can meet the determination of cefotiam hydrochloride for injection.