簡易高效能液相層析法對Ciprofloxacin之分析

本論文係建立一種簡易高效能液相層析法搭配紫外光偵測器，並佐以一般移動相溶媒之組成，對ciprofloxacin進行分析之研究，進而應用於市售製劑之含量分析以及人體血漿中濃度監測。利用逆相層析管柱RP-C18 column ( 150 × 4.6 mm; 5 μm )，以2％醋酸水溶液：乙腈＝84：16（v/v）之混合溶液為移動相，選用umbelliferone作為內部標準品，於波長280 nm下進行偵測。在基本分析方法上，檢量線範圍於0.51 ~ 130 μM，偵測極限為0.25 μM，相關係數（r）皆達到0.9999顯示此方法的定量性相當良好。而在同日內及異日間分析方法精密度及準確度方面，其相對標準偏差（R.S.D.）及相對誤差（R.E.）分別小於1.52％及3.00％ ( n = 5），回收率則大於96.6％。應用此法於市售製劑之含量分析時，其分析結果純度皆符合USP XXV版之規定（90.0∼110.0％）。於人體血漿分析中，所得之檢量線範圍則介於0.51 ~ 64.8 μM，偵測極限為0.25 μM，相關係數（r）亦達到0.9999顯示此方法有相當良好的定量性。而在同日內及異日間分析方法精密度及準確度方面，其R.S.D. 及R.E. 分別小於3.39％及5.71％ ( n = 6），回收率則大於93.9％。

關鍵字

高效能液相層析法；賽普沙辛

並列摘要

A simple and sensitive high performance liquid chromatography ( HPLC ) has been described for the quantitative analysis of ciprofloxacin in pharmaceuticals and human plasma. The method employed reversed phase chromatography on a RP-C18 column with an isocratic mobile phase of acetonitrile : 2% acetic acid aqueous solution ( 16 : 84, v/v ) with a flow rate 1.0 mL/min. The UV detector was set at 280 nm. The method was validated in terms of limit of detection ( LOD ), linear range, precision, accuracy, recovery, stability and selectivity. The HPLC method was applied to determine ciprofloxacin in pharmaceuticals ( tablets and injections ). The regression equations were linear between 0.51 ~ 130 μM ( r≧0.9999 ). The relative standard deviation ( R.S.D. ) and relative error ( R.E. ) of intraday and interday were less than 1.52% and 3.00%, respectively ( n = 5 ). The recoveries were greater than 96.6%. The method was also used to determine ciprofloxacin in human plasma. Plasma samples were simply deproteinized with acetonitrile. The regression equations were linear between 0.51 ~ 64.8 μM ( r ≧ 0.9999 ). The R.S.D. and R.E. of intraday and interday were less than 3.39% and 5.71%, respectively ( n = 6 ). The recoveries were all greater than 93.9%. The method had been successfully applied to monitor concentrations of ciprofloxacin on a human volunteer received a single oral dose in a 24 hours period.

並列關鍵字

Ciprofloxacin ； HPLC

參考文獻

1. Chin NX, Neu HC, Ciprofloxacin, a quinolone carboxylic acid compound active against aerobic and anaerobic bacteria, Antimicrobial Agents and Chemotherapy, 25, 319-326, 1984.

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2. Eliopoulos GM, Gardella A, Moellering RC, In vitro activity of ciprofloxacin, a new carboxyquinoline antimicrobial agent, Antimicrobial Agents and Chemotherapy, 25, 331-335, 1984.