Kedor-Hackmann E R, Gianotto E A, Santoro M I
Faculty of Pharmaceutical Sciences, University of São Paulo, Brazil.
Drug Dev Ind Pharm. 1998 Jun;24(6):553-5. doi: 10.3109/03639049809085657.
The simultaneous determination of betamethasone dipropionate (BD) and salicylic acid (SA) in both ointment and topical solution was developed using high-performance liquid chromatography (HPLC). The method was standardized using a LiChrospher 100 RP-18 (125 x 4 mm, 5 microns) column, acetonitrile-tetrahydrofuran-acetic acid 1% (25:20:55 v/v), apparent pH 3.3, as mobile phase, and UV detection at 254 nm. The peak area response versus concentration was linear in a concentration range from 5.0 to 50.0 micrograms/ml of BD and from 20.0 to 200.0 micrograms/ml of SA. The correlation coefficients were 0.9997 for BD and 0.9987 for SA, and the relative standard errors of estimates were 1.38% for BD and 3.27% for SA. The coefficient of variation and the recovery average were, respectively, 0.41-1.15% and 100.09% for BD, and 0.57-0.95% and 99.79% for SA.
采用高效液相色谱法（HPLC）建立了同时测定软膏剂和外用溶液中丙酸倍氯米松（BD）和水杨酸（SA）含量的方法。该方法采用LiChrospher 100 RP - 18（125×4 mm，5微米）色谱柱进行标准化，以乙腈 - 四氢呋喃 - 1%乙酸（25:20:55 v/v），表观pH 3.3作为流动相，并在254 nm处进行紫外检测。BD浓度在5.0至50.0微克/毫升范围内以及SA浓度在20.0至200.0微克/毫升范围内，峰面积响应与浓度呈线性关系。BD的相关系数为0.9997，SA的相关系数为0.9987，BD的估计相对标准误差为1.38%，SA的估计相对标准误差为3.27%。BD的变异系数和平均回收率分别为0.41 - 1.15%和100.09%，SA的变异系数和平均回收率分别为0.57 - 0.95%和99.79%。
