UFLC-MS Method Development of Vasicinone, Pellitorine, 6-Gingerol, Costunolide, Dehydrocostuslactone, Apigenin, and Validation of Piperine, Biflorin in Polyherbal Formulations

Abstract

Standardisation of polyherbal formulations is necessary for the quality, safety, quantity, and efficacy of botanicals in marketed and newly established formulations. The Ministry of Ayush, Govt of India, recommended using polyherbal formulations to treat COVID-19, i.e., Kabusura kudineer, Nilavembu kudineer, etc., Kabusura kudineer is a Siddha-based formulation. It prevents and treats COVID-19 due to some botanicals in Kabusura kudineer, which have proven anti-inflammatory, anti-viral, and immunomodulatory effects. The current work focuses on establishing a standard protocol for the Kabusura kudineer marketed, a novel dosage form called Hydaljss08, and in plant species, mainly present in both formulations. Both formulations contain some similar crude drugs and their active constituents. They are Zingiber officinale rhizome, Syzygium aromaticum flower buds, Adhatoda vasica leaves, Anacyclus pyrethrum roots, Saussurea lappa roots, Piper longum fruits, Clerodendrum serratum roots, Coleus amboinicus roots, contain active phytopharmaceuticals are 6-gingerol, biflorin, vasicinone, pellitorine, costunolide, dehydrocostuslactone, piperine, and apigenin. Existing liquid chromatography methods were reported for individual above active compounds, but not in these formulations and combined dosage forms. Working UFLC methods have not been reported individually nor combined for the Biflorin. The current study aims to develop UFLC methods for 6-gingerol, biflorin, vasicinone, pellitorine, costunolide, dehydrocostuslactone, piperine, and apigenin in polyherbal formulations Kabusura kudineer marketed, Hydaljss08 and in isolated, fractions, extract of plant species present in both dosage forms. The preliminary identification of the phytopharmaceuticals in the polyherbal formulations, isolated fractions, and extract of plant species was done by TLC and IR spectrum. The developed liquid chromatography method was novel, simple, linear, and rapid for estimating 6-gingerol, biflorin, vasicinone, pellitorine, costunolide, dehydrocostuslactone, piperine, apigenin in a plant species, and Ayush-based formulations.