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

許淑纓(Shu-Ying) ； 何智(Chig Ho) ； 徐廷光(Ting-Guang Shyu)

《藥物食品檢驗局調查研究年報》 6號 (1988/09) Pp. 50-55

https://doi.org/10.6946/ASRNL.198809.0050

摘要

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.×250mm)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。標準曲線(Standard Curve)之線性迴歸方程式為Y=0.1684 X-0.0064，相關係數r=0.9998（濃度範圍為0.085~0.425mg/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。

關鍵字

Thioctamide ； 鑑別 ； 含量測定 ； 高效液相層析法

並列摘要

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 (PC 8-10, 10μm, 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.