高壓液相層析法對製劑中水溶性維他命與 Silybin 的同時性分析

維他命分為水溶性與脂溶性兩種,其共同的特點為均扮演著人體中酵素合成的重要輔助因子。Silymarin (主要活性成份Silybin)有保肝的作用,可緩解肝硬化以及肝炎,維他命與Silymarin 的合併使用常應用於市售的保肝製劑中。本篇以HPLC C18 column (4.5mm×250mm, 5 μm particle size) 為固定相,利用50 mM KH2PO4 pH7.0 (solvent A), Methanol (solvent B), Acetonitrile (solvent C),以gradient 移動相模式,同時分析水溶性維他命Thiamine HCl, Riboflavin, Nicotinamide, Calcium Pantothenate, Pyridoxine HCl 與一種非水溶性物質 Silybin。本法HPLC 條件在流速1.0 ml/min下,整體分析時間需要18分鐘,所得的分析物以UV 220 nm 檢測,同時可以應用於市售的保肝製劑中,檢測 Thiamine HCl, Riboflavin, Nicotinamide, Calcium Pantothenate, Pyridoxine HCl 與 silybin 的含量。本法分析前僅需以Methanol對檢品進行萃取,recovery 可達 98.3%~101.6%, 再現性良好(RSD < 2.0%),對市售水溶性維他命與silymarin 製劑之品管分析,甚具應用潛力。

關鍵字

製劑；維他命

並列摘要

Vitamins can be divided into water-soluble and fat-soluble compounds. Their mutual role is function as cofactors in enzyme biosynthesis; and silymarin (with silybin as the main ingredient) is a liver protection compound, frequently used with vitamins in many formulations . An HPLC method is described for the analysis of thiamine HCl, riboflavin, nicotinamide, calcium pantothenate, pyridoxine HCl and one water-insoluble compound, silybin, using C18 column (4.5mm×250mm, 5μm particle size) as the stationary phase and a gradient mobile phase with 50 mM KH2PO4 ( pH7.0, solvent A), Methanol (solvent B), and Acetonitrile (solvent C). The separation was attained within 18 min with a flow rate 1.0 ml/min and the UV detection was performed at 220 nm. The method was applied to quantification of thiamine HCl, riboflavin, nicotinamide, calcium pantothenate, pyridoxine HCl and silybin in commercial products with good recovery (98.3%~101.6%) and precision (RSD< 2.0%). It showed that the analytical method has high potential in QC testing of formulations of vitamins and silybin used in commercial products.