Novel HYDALJSS08 Polyherbal Formulation Development and Ultra-Performance Liquid Chromatographic Separation, Estimation of Gallic Acid in Terminalia chebula Dried Fruits, and a Marketed Siddha-based Polyherbal Formulation “Kabusura Kudineer”

Abstract

The Siddha-based polyherbal formulation known as “Kabusura Kudineer (Marketed)” contains fifteen plants materials in dried raw form and The Ayush Ministry, Govt. of India highly endorsed for use of “Kabusura kudineer” during the pandemic of COVID-19, due to its immuno-booster properties. The current study aims to develop and document an analytical strategy for the estimation of gallic acid (GA) and methyl, ethyl acetate fraction of Terminalia chebula dried fruits and in polyherbal formulations (Marketed, & Developed). One of the active substances of Kabusura Kudineer and developed “HYDALJSS08” Polyherbal formulation is Myrobalan (T. chebula dried fruit-Combretaceae). Myrobalan restrains active principal substances are GA. GA is proven for its Anti-viral and immunomodulatory activity. During the pandemic of, COVID-19 ministry of Ayush, Govt of India highly recommended the immuno-booster Siddha-based polyherbal formulation “Kabusura Kudineer” for immune-boosting and treatment of COVID-19. TLC, and FTIR carried out the preliminary identification of GA and the sample. The HPLC method was developed on an Inertsil C18 (150*4.6 mm and 5 μm) column. The mobile phase was enhanced for water: Acetonitrile (50:50). The flow rate was 1-mL/min and was GA tracked at 272 nm in a UV detector. The total run time of the chromatogram is 8 minutes and the retention time of GA is observed. The Rf value of GA and sample was found to be 0.27. Validation was carried out according to ICH guidelines. The retention time of GA was 2.2 min, and the Valid parameter of GA is system precision, SD (14247.75), %RSD (0.9), Regression equation y = 25511 x−947505, Correlation coefficient (R2) 0.9999. The adequate Linearity concentration was found to be 50 to 150 μg/mL, LoDs (1.70 μg/mL), LoQs (5.16 μg/mL), Method precision %RSD (0.8), SD (11626.7), Recovery 99.8, and 101.1%. GA content was found in a formulation (“Kabusura Kudineer”- 1.39 μg/mL, developed “HYDALJSS08” Polyherbal formulation-379.4 μg/mL), and ethyl, methyl acetate fraction of T. chebula dried fruits was 105.59 and 29.17 μg/mL. The developed (HPLC) UPLC methods have enabled novel, simple, accurate, rapid, easy, reproducible, rugged, and linear analysis in these two fractions, and Siddha-based formulation “Kabusura kudineer” (Marketed), a developed “HYDALJSS08” Polyherbal formulation.