Abstract

In India, Ayurvedic medicine has its own significance and dominance in the Indian Medicine System. The traditional medicine system of India is not well renowned due to the lack of standardization of herbal drugs. To assess the quality, purity, efficacy, potency, and safety of herbal drugs, standardization is the major aspect. Recently, World Health Organization (WHO) and European Medicines Agency (EMEA) have issued guidelines for the quality control of herbal drugs. The aim of the present study is the standardization of the coded polyherbal tablet formulation AYUSH SG-5. A scientific methodology was adopted to perform the standardization parameters like organoleptic parameters, microscopic, macroscopic, physico-chemical analysis, and high-performance thin-layer chromatographic (HPTLC) profiling of AYUSH SG-5. The HPTLC study has exhibited the presence of various phytochemicals such as 6-gingerol in Sunthi ( Zingiber officinale rhizomes), Epicatechin in Vetas (stem bark of Salix alba ), Colchicine in Suranjan ( Colchicum luteum corms), Resveratrol in Chopchini ( Smilax china tuber), Guggulsterone E & Z in Guggul ( Commiphora wightii resin). Based on the results of the present study, a monograph was proposed in the interests of quality control of the AYUSH SG-5. This research will help pharmacists to develop the formulation of AYUSH SG-5 with greater reproducibility and this document could be treated as a pharmaceutical standard operating procedure (SOP) for the production of AYUSH SG-5 in pharmacy. • A polyherbal ayurvedic tablet formulation AYUSH SG-5 for rheumatoid arthritis is prepared. • A scientific methodology was adopted to perform the standardization of AYUSH SG-5. • Organoleptic parameters, microscopic, macroscopic studies performed as per API. • Physico-chemical tests and HPTLC profiling of AYUSH SG-5 was performed. • In HPTLC study, marker compounds like 6-gingirol, Epicatechin, Colchicine, Resveratrol, guggulsterol E & Z in Guggul were identified. • A validated SOP was purposed for preparation and standardization of AYUSH SG-5.

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