Abstract

The herbal or alternative medicines having their own significances in each country. The major problem behind the non-acceptance of the alternative medicines is the poor standardization and quality control. Maximum times, it’s impossible to quantify the complex matrix of polyherbal medicines. The pharmacopeial standards of these medicines are limited to physicochemical and pharmacognostic analysis only, which are insufficient for the proper quality control of ingredients used for the preparation of polyherbal formulations. Multi-markers-based analysis of alternative medicines and their polyherbal formulations by using the sophisticated analytical techniques like HPLC, and LC-MS is the demand of current scenario. In our recent report we have reported pharmaceutical standard operating procedure for a coded polyherbal formulation (CPF i.e. AYUSH-SG-5) which was prepared for the rheumatoid arthritis. The marker-based quantification and identification of major metabolites and shelf-life (marker-based) studies were not reported in that study. In this report we have quantified eight markers (6-Gingerol, 8-Gingerol, Guggulsterone-E, Guggulsterone-Z, Resveratrol, Salicin, Colchicine, and Caffeic acid) simultaneously by HPLC chromatography. To identify the phytochemicals in polyherbal formula (CPF), LC-QTOF-MS/MS analysis was performed, where 32 main phytochemicals were identified out of 80 peaks. In herbal industry, HPTLC is the main tool for drug quantification, so we have reported a HPTLC method for the real time shelf-life study. In HPTLC study, we have used three major markers (6-Gingerol, Guggulsterone-E, Guggulsterone-Z) that are reproducible in hydroalcoholic extract and not in aqueous and methanolic extracts of CPF. The kinetic study-based shelf-life of CPF formulation was performed, the observed shelf-life of CPF was more than 41 months. In addition, evaluation of antioxidant activity like total phenolic (TPC), total flavonoid (TFC) and DPPH assays were performed, and results exhibited that hydroalcoholic extract having more values than aqueous and methanolic extracts of CPF. The phytochemicals observed in LC-QTOF-MS/MS studies were tested for in silico anti-inflammatory activity and anti-arthritic activities, which need to be explored after the detailed pharmacological and biological studies. Overall, analytical studies result of present study could use to standardize the CPF as well as the all relevant polyherbal formulations where these raw drugs have been used.

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