應用液相層析法測定Isosorbide Nitrate及其類似物與其製劑   全文下載

Determination of Isosorbide Nitrate and Its Analogues in Pharmaceuticals by High-Performance Liquid Chromatography

逆相高效液相層析法已發展利用於鑑別及測定isosorbide dinitrate （ISDN）, isosorbide 5-monoitrate （IS5MN）及其降解物isosorbide 2-mononitrate （IS2MN），同時應用於分析此二成分之製劑。整個高效液相層析系統由Waters 600型幫浦，700型之自動檢體採樣機與高容量檢品注射圈活瓣、486型可變波長之紫外光偵測器，偵測波長設定於220 nm及用於圖譜積分之745 B型積分儀組成。以C18 （3.9 mm × 250 mm, 10 um i.d.）之層析管於間濃度移動相pH 4.75含sodium hexanesulfonic acid-acetonitrile，流速1.5 ml／min，於三十分鐘內能將ISDN，IS5MN，內部標准品4-aminoacetophenone及ISDN之次要代謝物，亦為降解物完全分離並予以定量，本研究所用之方法僅須單一移動相即能將所欲分離isosorbide nitrate esters完全分離。0.05至2.5 mg／ml之標準溶液稀釋液之校正係數分別測定如下：ISDN, r = 0.9998及標準偏差0.48%; IS5MN, r = 0.9999及標準偏差0.08%; IS2MN, r = 0.9999及標準偏差0.05%。由市售口服錠、持續錠及乳糖稀釋之ISDN原料藥應用本研究所發展之方法其回收率均大於98%。因此研究所使用之分析方法快速、簡單又確實可用。"

A reversed-phase column liquid chromatographic method was developed for analysis of isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (IS5MN) and isosorbide 2-mononitrate (IS2MN) and its pharmaceuticals. Chromatography is performed to Bondclone ODS column using a mobile phase consisting of acetonitrile-PIC B6 buffer, pH 4.75 (13:87) with ultraviolet wavelength at 220 nm. The linearity calibration range was 0.05 mg/ml to 2.5 mg/ml (r=0.9999), and recoveries were generally greater than 98.0%.