HPLC法同时测定氯霉素倍他米松搽剂中三组分的含量

Simultaneous Determination of Three Components in Chloramphenicol and Betamethasone Liniments by HPLC

目的建立同时测定氯霉素倍他米松搽剂中水杨酸、氯霉素、倍他米松含量的HPLC方法。方法用AgilentC18(4.6 mm×250 mm,5μm)色谱柱,以甲醇-0.34%磷酸二氢钾溶液(50∶50)为流动相,流速1.0 ml·min^(-1),检测波长为240 nm,进样量:20μl,柱温:30℃。结果水杨酸、氯霉素、倍他米松的检测线性范围分别为0.040 48~0.8096 mg·ml^(-1)(r=1.000)、0.019 94~0.3988 mg·ml^(-1)(r=1.000)、0.001 492~0.029 84 mg·ml^(-1)(r=0.999),重复性试验RSD值均小于0.7%;平均加样回收率分别为99.81%(RSD为0.53%,n=9)、98.91%(RSD为0.34%,n=9)、99.33%(RSD为0.80%,n=9)。结论该方法简单、灵敏、准确,可用于该制剂的含量测定。

Objective To establish an HPLC method for simultaneous determination of salicylic acid,chloramphenicol and betamethasone in chloramphenicol and betamethasone liniments. Methods The sample was separated and analyzed on the Agilent-C18（ 4. 6 mm × 250 mm,5 μm） column,with CH3OH-0. 34% KH2PO4（ 50∶ 50） as the mobile phase. The flow rate was at 1. 0 ml·min^-1,the detection wavelength was at 240 nm,the injection volume was 20 μl,and the column temperature was 30 ℃. Results Salicylic acid showed a good linear relationship within the range of 0. 040 48-0. 8096 mg·ml^-1（ r = 1. 000）,chloramphenicol within the range of 0. 019 94-0. 3988mg·ml^-1（ r = 1. 000）,and betamethasone within the range of 0. 001 492-0. 029 84 mg·ml^-1（ r = 0. 999）. The RSD value the repeatability test was less than 0. 7%. The average recovery was 99. 81%（ RSD = 0. 53%,n = 9）,98. 91%（ RSD = 0. 34%,n = 9） and 99. 33% respectively（ RSD = 0. 80%,n = 9）. Conclusion This method is simple,sensitive and accurate,which can be used for quality control of this preparation.