本文選題：高效液相色譜法 + 鹽酸異苯環(huán)戊胺�。� 參考：《國(guó)際藥學(xué)研究雜志》2017年08期

【摘要】：目的建立測(cè)定鹽酸異苯環(huán)戊胺膠囊含量及溶出度的方法。方法采用高效液相色譜法,色譜柱為Diamonsil C18柱(150 mm×4.6 mm,5μm);流動(dòng)相為0.02 mol/L磷酸二氫鉀溶液(加0.1%三乙胺,用磷酸調(diào)節(jié)pH值至3.0)-甲醇-乙腈(30∶35∶35,V/V/V);流速為1.0 ml/min;檢測(cè)波長(zhǎng)為224 nm;柱溫為40℃。溶出度測(cè)定采用轉(zhuǎn)籃法,分別以0.1 mol/L鹽酸溶液、pH4.5醋酸鹽緩沖液、水、pH 6.8磷酸鹽緩沖液500 ml為溶出介質(zhì),以50、75和100 r/min為轉(zhuǎn)速,篩選溶出條件。結(jié)果該法專屬性良好,含量測(cè)定的線性范圍為20.74~155.58μg/ml(r=1.0000),平均回收率為100.1%;溶出量測(cè)定的線性范圍為2.08~24.90μg/ml(r=0.9998),平均回收率為98.9%。確定了以0.1 mol/L鹽酸溶液為溶出介質(zhì)和50 r/min為轉(zhuǎn)速的溶出度測(cè)定方法。3批膠囊的含量和溶出度均符合規(guī)定。結(jié)論該法簡(jiǎn)便、準(zhǔn)確、重現(xiàn)性好,可用于鹽酸異苯環(huán)戊胺膠囊的含量及溶出度測(cè)定。
[Abstract]:Objective to establish a method for determination of isobenocyclopentylamine hydrochloride capsules content and dissolution.Methods High performance liquid chromatography (HPLC) was used. The column was Diamonsil C18 column (150mm 脳 4.6mm ~ 5 渭 m) and the mobile phase was 0.02 mol/L potassium dihydrogen phosphate solution (0.1% triethylamine, 0.1% triethylamine).The pH value was adjusted with phosphoric acid to 30: 35: 35: 35: 35 V / V / V / V, the flow rate was 1.0 ml / min, the detection wavelength was 224 nm, and the column temperature was 40 鈩，

本文編號(hào)：1746732