中国临床药学杂志

目的建立测定磺胺醋酰钠滴眼液中磺胺醋酰钠含量的HPIC法。方法采用Spursil C₁₈-EP(250 mm×4.6 mm,5μn)色谱柱,流动相:水-甲醇(20:80),柱温20℃,流速1 mL·min^-1,检测波长258 nm。外标法计算含量。结果在该色谱条件下,磺胺醋酰钠在质量浓度6~100 mg·L^-1内线性良好(r>O.999,n=7),加样回收率为97%~103%(n=3),精密度试验中RSD<2.0%(n=5)。样品在24h内稳定。测得样品含量合格,为95%~105%。结论本方法简便快速,所测结果准确可靠,重复性好,可用于测定磺胺醋酰钠滴眼液中磺胺醋酰钠的含量。

AIM To develop a high performance liquid chromatography(HPLC) to determine sulfacetamide sodium in sulfacetamide sodium eye drops.METHODS The I-IPLC separation was carried out on a Spursil C₁₈-EP(250 mm×4.6mm,5μm) column,using a UV detector with the 258 um wavelength.The mobile phase was water-methanol solution(20:80) with the velocity of 1 mL·min^-1and the column temperature of 20℃.RESULTS The good linearity of sulfacetamide sodium under chromatography was found(r>0.999,n=7).The recovery values were between 97% and 103%(n=3).The RSD values were below 2.0%(n=5).The samples were stable in 24 h.The samples reached standardized qualification.CONCLUSION HPLC is proved to be simple,swift,accurate,and reliable and reproducible for the content determination of sulfacetamide sodium in sulfacetamide sodium eye drops.