HPLC法测定复方间苯二酚搽剂中间苯二酚、摘要.doc

HPLC法测定复方间苯二酚搽剂中间苯二酚水杨酸醋酸氟轻松的含量 陈晓亮1＊，汪旭2＃（1.海口市人民医院，海南 海口 570208；2.长春八一医院，吉林 长春） ＊主管药师，硕士。研究方向：医院药学。电话：（0898E-mail ＃主管药师，硕士。研究方向：药剂学。电话：（0431E-mail：wangxujlu@ [摘要] 目的：建立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。方法：采用高效液相色谱法。色谱柱为WondaSil C18 (250mm ×4.6 mm ,5μm)，流动相甲醇-乙腈-0.1%磷酸溶液（55:10:35），流速为1.0 ml·min-1，柱温为30℃，波长：240nm，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16～56μg、10～35μg和0.08～0.28μg；精密度、稳定性、重复性试验的RSD0.50%；平均加样回收率分别为99.05% (n=6， RSD=0.70%)、100.16% (n=6RSD=0.63%)和99.20% (n=6，RSD=0.81%)。结论：本方法结果准确，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。 [关键词] 复方间苯二酚搽剂；HPLC；间苯二酚；水杨酸；醋酸氟轻松 Determination of Resorcinol Salicylic acid and Fluocinonide in Compound Resorcinol Liniment by HPLC CHEN Xiao-liang1 WANG Xu2 （1.Haikou people’s hospital , Haikou 570208 , China；2.Deparement of Pharrmacy,Bayi hospital of Changchun, Changchun 130024 , China） [Abstract] OBJECTIVE:To establish a HPLC method for determination of Resorcinol Salicylic acid and Fluocinonide in Compound Resorcinol Liniment. METHODS: HPLC method was adopted. The determination was performed on WondaSilC18 (250mm×4.6mm,5μm) with mobile phase of methanol-acetonitrile-0.1% phosphoric acid (55:10:35) at flow rate of 1.0 ml·min-1, the column temperature was maintained at 30℃，the wavelength was set at 240nm and the injection volume was 10μl. RESULTS:The linear range was16～56μg for Resorcinol, 10～35μg for Salicylic acid and 0.～0.28μg 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． [Key words] Compound Resorcinol Liniment; HPLC; Resorcino; Salicylic acid; Fluocinonide 复方间苯二酚搽剂由间苯二酚、水杨酸和醋酸氟轻松及辅料组成的外用制剂，在临床应用多年，疗效确切。醋酸氟轻松其疗效显著而副作用较小可真皮毛细血管收缩，抑制表皮细胞再生或增殖，溶酶体酶释放引起的组织损伤。具有较强的抗炎抗过敏作用用