高效液相色谱法测定复方间苯二酚搽剂中间苯二酚、水杨酸及醋酸氟轻松的含量

Content determination of resorcinol salicylic acid and fluocinonide in compound resorcinol liniment by HPLC

目的建立高效液相色谱(HPLC)法测定复方间苯二酚搽剂中间苯二酚、水杨酸和醋酸氟轻松的含量。方法采用HPLC法。色谱柱为WondaSil C_(18)(250 mm×4.6 mm,5μm),流动相组成为甲醇-乙腈-0.1%磷酸溶液(55∶10∶35),流速为1.0m L·min^(-1),柱温为30℃,紫外检测器波长:240 nm,进样量:10μL。结果间苯二酚、水杨酸和醋酸氟轻松检测质量的线性范围分别为16~56、10~35和0.08~0.28μg;精密度、稳定性、重复性试验的RSD≤0.50%;平均加样回收率分别为99.05%(n=6,RSD=0.70%)、100.16%(n=6,RSD=0.63%)和99.20%(n=6,RSD=0.81%)。结论该方法结果准确,精密度高,可同时测定间苯二酚、水杨酸和醋酸氟轻松的含量,可用于此制剂的质量控制。

Objective To establish an HPLC method for determination of content of resorcinol salicylic acid and fluocinonide in compound resorcinol liniment. Methods HPLC method was adopted. The determination was performed on Wonda Sil C18（ 250 mm × 4. 6mm,5 μm） with mobile phase of methanol-acetonitrile-0. 1% phosphoric acid（ 55∶ 10∶ 35） at flow rate of 1. 0 m L·min-1. The column temperature was maintained at 30 ℃. The UVD wavelength was set at 240 nm and the injection volume was 10 μL. Results The linear range was good within 16 ~ 56 μg for resorcinol,10 ~ 35 μg for salicylic acid and 0. 08 ~ 0. 28 μg for fluocinonide. RSDs of precision,stability and reproducibility tests were not higher than 0. 50%. Average recoveries were 99. 05%（ n = 6,RSD = 0. 70%）,100. 16%（ n = 6,RSD = 0. 63%） and 99. 20%（ n = 6,RSD = 0. 81%）,respectively. Conclusions The method is accurate and can be used in content determination of resorcino salicylic acid and fluocinonide in compound resorcinol liniment at the same time. The method can also be used in the quality control of the preparations.