高效液相層析法測定製劑中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

本文提供一簡單，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Aryloxypropano1amine類交感神經β-感受體遮斷劑： Atenolol, Metoprolol Tartrate, Oxprenolol Hydroch1oride, Pindolol，及Propranolol Hydroch1oride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 x 4,5μm），移動相為472.4mg 1-hexane-su1fonic acid sodium sa1t溶於500m1水，330ml 甲醇，170ml 乙腈與0.56ml冰醋酸混合液。流速1.5ml/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（Pindo1ol以外製劑）或0.1N鹽酸（Pindolol製劑）萃取即可。定量時以Oxprenolol Hydroch1oride（Oxprenolo1 Hydroch1oride以外製劑）或Metoprolol Tartrate（Oxprenolol Hydroch1oride製劑）為內部標準品。本法之再現性良好，變異像數小於2%。回收率分別是：Atenolol 98.4%, Metoprolol Tartrate 102.3%, Oxprenolol Hydroch1oride 100.2%, Pindolol 100.2%, Propranolol Hydroch1oride 100.0%。

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 extraction of 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 275 nm.the durationof each analysis is less than 10 min. Average recoveries are 98.4%, 102.3 %, 100.2%, 100.2%, and 100.0% for compounds I - V, respectively.