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高效液相層析法測定製劑中之Atenolol, Metoprolol Tartrate, Oxprenolol Hydrochloride, Pindolol及Propranolol Hydrochloride

High-Performance Liquid Chromatographic Determination of Atenolol, Metoprolol Tartrate, Oxprenolol Hydrochloride, Pindolol and Propranolol Hydrochloride in Pharmaceutical Dosage Forms

摘要


本文提供-簡單,快速之逆相離子配對高效液相層析法,可同時分離,鑑別並定量五種Aryloxypropanolamine類交感神經β-感受體遮斷劑:Atenolol, Metoprolol Tartrate, Oxprenolol Hydrochloride, Pindolol,及Propranolol Hydrochloride之製劑。 本法採用之逆相離子配對高效液相層析系統包括:Lichrospher100 RP-8層析管(12.5cm×4,5μm),移動相為472.4mg 1-hexane-sulfonic acid sodium salt溶於500ml水,330ml甲醇,170ml乙腈與0.56ml冰醋酸混合液。流速1.5m/min,偵測波長275nm,層析時間約8分鐘。 本法之檢體前處理簡易,僅須以甲醇(Pindolol以外製劑)或0.1N鹽酸(Pindolol製劑)萃取即可。定量時以Oxprenolol Hydrochloride (Oxprenolol Hydrochloride以外製劑)或Metoprolol Tartrate (Oxprenolol Hydrochloride製劑)為內部標凖品。本法之再現性良好,變異係數小於2%。回收率分別是:Atenolol 95.4%, Metoprolol Tartrate 102.3%, Oxprenolol Hydrochloride 100.2%, Pindolol 100.2%, Propranolol Hydrochloride 100.0%。

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並列摘要


A high-performance liquid chromatography is presented for determining atenloll (Ⅰ), metoprolol tartrate (Ⅱ) oxprenolol hydrochloride (Ⅲ), pindolol (Ⅳ), propranolol hydrochloride (Ⅴ) in commercialformulations. The method consists of an extractionof samples with methanol or 0.1N hydrochloric acid, separated on an octylsilane column with a mixture of water, methanol, acetonitrile, and acetic acid (500:300:170:0.56) containing 472.4mg sodium 1 hexanesulfonate as a mobile phaseand detected at 275nm. the durationof each analysis is less than 10mm. Average recoveries are 98.4%, 102.3%, 100.2%, 100.2%, and 100.0% for compounds Ⅰ-Ⅴ, respectively.

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