ESTABLISHMENT OF INTERNAL STANDARD FOR QUALITY ASSESSMENT OF TABLET FROM TRADITIONAL MEDICINE OF TAO HONG SI WU

Abstract

Tao Hong Si Wu tablets are a modern dosage form developed from a traditional medicine has good effects in treating menstrual disorders and cardiovascular diseases. This study was conducted with the purpose of developing a set of internal standards to evaluate the quality of Tao Hong Si Wu tablets to ensure safety, effectiveness, quality and stability of the product. Ferulic acid in Tao Hong Si Wu tablets is chosen as a Q-marker and a quantitative process was developed using the HPLC method validated based on AOAC standards. The analysis was performed by using an reverse-phase C₁₈ column (5 µm x 4.6 x 100 mm) on the HPLC-DAD system with an socratic mobile phase of acetonitrile and phosphoric acid 0.2% (13.5:86.5), and a flow rate of 1 ml/min at UV 320 nm. The regression equations are linear (y = 219.59x, R² = 0.9986) in a range between 0.51 – 2.54 µg/ml. The intra-day and inter-day relative standard deviation are 3.4% espectively. All the recoveries ranged from 80.0% to 110.0%. This study successfully establish a set of internal standards including quality indicators: properties, mass uniformity, disintegration, hardness, abrasion, qualitative and quantitative (ferulic acid).