Development of Quality Control Parameters of Hepasave Syrup

Abstract

Development of quality control parameter of Hepasave syrup Herbal medicines can be used one type of complementary and alternative medicine. People use herbal medicines to try to maintain or improve their health. Many people believe that products labelled "natural" are always safe and good for them. In recent era, there has been great demand for herbal products in developed countries. So it is necessary to perform evaluation of polyherbal formulation. The present research work aims for development of quality control parameters of HEPASAVE syrup, a polyherbal formulation. HEPASAVE syrup has been procured from Cadila Pharmaceuticals Ltd. It is basically used as hepatoprotective agent, bitter tonic and antioxidant. It is the lozenges solution which is made of combination of few medicinal plants, Phyllanthus emblica, Terminalia chebula, Terminalia bellerica , Adhatoda vasica , Andrographis paniculata, Picrorrhiza kurroa. The work is carried for the total investigation of the formulation & it’s biomarkers, various parameters like organoleptic character, physico chemical parameter, phytochemical screening, identification of biomarkers, fractionation of formulation were studied. Determination of bitterness value, extractive value were also studied. HPLC trials, forced degradation studies, microbiological studies, estimation of phytoconstituents & detection of heavy metals were also studied. The results of physicochemical parameters, were found about 4.16,1.33gm/ml and 1560poise respectively of pH, density, viscosity. Detection of secondary metabolites like alkaloids, glycosides, etc by performing phytochemical screening. Estimation of total phenolic content, total flavonoid content and for starch & carbohydrates were 0.23,0.25,0.44 and 0.32%w/v respectively. Microbiological studies shows total viable count was found to be in limit in fungi and in bacteria as per WHO guidelines. The zone of inhibition was performed on E.Coli, B.Subtilus, and St.aureus and found to be more effective against st.aureus. Extractive value has performed taking 4 solvents and maximum extractive value was found in toluene which shows high presence of flavonoid. Bitterness value was performed in reference to quinine sulphate and the value was found to be in limit. The maximum wavelength of the gallic acid, tannic acid and vasicine were found to be 271, 280,260. Preliminary investigation of the biomarkers were performed using TLC and the Rf value were found 0.38 in gallic acid, 0.2875 in vasicine and 0.27 in andrographolide. RP-HPLC method was performed to detect presence of biomarkers like gallic acid, tannic acid using mobile phase acetonitrile :water (10:90) maintaining pH 3 and Rt value was found to be near 4.5 and 6 minute. The Photolytic studies were performed on gallic acid and tannic acid which were found to be 31.31μg/ml & 60.48μg/ml respectively. In the pH degraradation study it was noted that as pH increases (alkaline condition) k value & %degradation decreases & concentration increases. The force degradation studies for the drug extract using stressor was also performed. The % degradation in acidic condition (3N HCl for 60& 90 minute) was 30 & 50% at 60& 90 minutes respectively for gallic acid & tannic acid was 22.22, 44.44, 26.46, 29.47 % respectively. In alkaline condition (0.1N NaOH for 60& 90 minute) was 33& 53.3 % at 60& 90 minutes. For gallic acid & tannic acid it was 10, 20 & 68.17%. The dry heat degradation was 65.66% for the extract & for the gallic acid & tannic acid was 4% & no change in tannic acid. The oxidative degeneration was 33% for the extract & for gallic acid & tannic acid was 26 &22 % respectively.