以高效液相層析法定量複方強肝錠劑中之Thioctamide成分

DETERMINATION OF THIOCTAMIDE IN TABLETS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

本研究發展出一種高效液相層析法，可用於分離、定量單方或複方強肝錠劑中之 Thioctamide 成分，簡單、迅捷且具特異性。使用 Shimadzu PC 8-10 （10μm, 4mm I.D. x 250 mm） 為層析管，以1%冰醋酸與乙腈（60:40）之混合液為移動相，Clofibric Acid 為內部標準品，於250nm 波長處以紫外光偵測器偵測之。標準曲綫 （Standard Curve） 之綫性迴歸方程式為 Y = 0.1684 X-0.0064，相關係數 r= 0.9998 （濃度範圍為0.085～0.425 mg/ml）。注射不同濃度之模擬檢體各六次，所得平均回收率為100.95%，市售檢體含量測定實驗之變異係數為0.48%，顯示本法準確、可靠，適用於市售藥品錠劑之檢驗分析。

A simple, rapid and specific method of high-performance liquid chromatography for the separation and determination of thioctamide in pharmaceutical priparations has been developed. In this study the mobile phase was a mirxed solvent which contain 40% acetonitrile and 60% aqueous solution of 1% acetic acid , the internal standard was clofibric acid, the detection wavelength was set at 250 nm, the column was the product of Shimadzu Company (PC8-10, 10,μm, 4mm I.D. × 250 mm), the flow rate of mobile phase was 1 ml/ min. Results indicated an equation of the regression analysis for a standard curve (concentration of thioctamide versus peak height ratios) was Y = 0.1684 X -0.0064 , and coefficient of correlation(r) for the analysis was 0. 9998 (from 0.085 mg/ml to 0. 435 mg/ ml). Recovery studies of model sample solutions gave a value of 100.95% (n= 6). The coefficient of variation for the assay of a marketed product was 0.48%, We conclude that this study provides a precise and reliable method which is applicable to the analysis of commercial tablets.