盐酸特比萘芬乳膏，盐酸特比萘芬溶液，盐酸特比萘芬喷雾剂中主要物质含量检测方案(液相色谱柱)

HPLCDATA'SHEET 儿十7酸液液·又一·一Terbinafine hydrochloride solution， spray and cream A110721C A) System suitability solution*(0.0175 mg/mL p-Terphenyl， 0.2 mg/mL Terbinafine hydrochloride)mAU 200 System suitablity result requirement Resolution (1，2) 26 13.5 1. B) Sample solution* (0.2 mg/mL Terbinafine HCI) p-Terphenyl mAU 2. CH3 H3C CH3 ·HC Terbinafine hydrochloride *System suitability solution was prepared from Terbinafine HCI supplied as a reagent for laboratory use.Sample solution was prepared from Terbinafine HCI solution. Column ： YMC-Pack ODS-A (5 um， 30 nm) 125X4.0mml.D. Eluent ： acetonitrile/tetrahydrofran/buffer* (40/20/40) * Dissolve 9 mL of 10% tetramethylammonium hydroxide in 2000 mL water， adjust pH 8.0 with H3PO4(1→25) Flow rate ： 1.1 mL/min (adjust the flow rate so that the retention time of terbinafine is about 8.5 min) Temperature ：25℃ Detection ： UV at 282 nm Injection ： 10uL (The Japanese Pharmacopoeia 16th ； Assay) 盐酸特比萘芬乳膏（喷雾剂、溶液）含量测定色谱条件（JP VXI） 仪  器：液相色谱仪检测器：UV (282nm)色谱柱：YMC-Pack ODS-A色谱柱（内径：4.0mm  长度：125mm  粒径：3um  孔径：30nm）流动相：乙腈-四氢呋喃-缓冲溶液* 2:1:2   *缓冲溶液：将9克四甲基氢氧化铵溶解于2000ml水中，并用稀磷酸溶液（1:25）调pH至8.0柱  温： 25℃流  速：1.1ml/min（调整特比萘芬色谱峰保留时间约8.5分钟）进样量：10ul（0.2mg/ml） 系统分离度：取适量盐酸特比萘芬和p-三联苯溶于甲醇，浓度分别为0.2mg/ml和0.0175mg/ml。取10ul进样，p-三联苯和特比萘芬的分离度不小于6。    系统重复性：RSD≤1.0%