應用高效液相層析法分離、定量錠劑中Propyphenazone及Trasentine二成分

SEPARATION AND DETERMINATION OF PROPYPHEN AZONE AND TRASENTINE IN TABLETS USING LIQUID CHROMATEGRAPHY

一種簡便的恒組成高效液相層析法（HPLC）已被發展來分離及定量錠劑中Propyphenazone 及 Trasentine 二成分。在本法中，Flutamide 被引用來作為內部標準品（Internal Standard）。所用的藥錠檢體係經90%甲醇直接抽提步驟製備而成溶液。所有的標準品溶液則皆以甲醇為溶媒配製而成。HPLC的層析條件包括：流速為1.5 ml/min；逆相層析管為μ-Bondapak(TM)C-18 （10μm; 3.9mmI.D×300mm）；紫外光偵測器（UV detector） 的波長設定為220 nm；移動相為甲醇/0.05 M KH2 PO4，pH 4.8（70:30） 混合溶液。結果發現二者標準曲線（Standard Curve）之相關係數（Coefficient of Correlation）皆在0.9997以上；而容積因子（Capacity Factor）分別為K'（propyphenazone） = 1.177，K'（flutamide） = 2.558，K'（trasentine） =4.568；回收率分別為100.3% （propyphenazone） 及101.1% （trasentine）；實際檢體中有效成分含量測定之變異係數（coefficient of variation, C.V.）均小於2%。利用本法，分析所需時間可縮短；層析分離可在十分鐘以內完成。

A simple isocratic, high-performance liquid chromatography (HPLC) assay procedure was proposed for the simultaneous determination of propyphenazone and trasentine in sugar coated tablets, using flutamide as an internal standard. Tablet samples were extracted by direct dissolution in 90% methanol. All standards were dissolved by methanol. The chromatographic conditions included: flow rate= 1.5 ml/min; μ-Bondapak(TM) C-18 column (10μlm, 3.9 mm I.D. × 300 mm); 220 nm UV detector. The mobile phase, consisted of methanol and 0.05 M KH2 P04, pH 4.8 (70:30) mixture. Coefficients of Variation of 1.26% and 0. 49% were obtained for propyphenazone and trasentine respectively. The method is pretty rapid, accurate and reliable. Analysis time is reduced to minimum and the chromatographic separation is complete within 10 minutes.