The validated pharmaceutical standard operating procedure and quality control study of the coded polyherbal tablet formulation AYUSH SG-5

In India, Ayurvedic medicine has its own significance and dominance in the Indian Medicine System. The tra-ditional 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 poly -herbal 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), Epicate-chin in Vetas (stem bark of Salix alba), Colchicine in Suranjan (Colchicum luteum corms), Resveratrol in Chop-chini (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.(c) 2022 SAAB. Published by Elsevier B.V. All rights reserved.

Automated summary

Ayurvedic medicine holds significant importance and dominance in the Indian Medicine System. However, the lack of standardization of herbal drugs has hindered the recognition of India's traditional medicine system. Standardization plays a crucial role in assessing the quality, purity, efficacy, potency, and safety of herbal drugs. Recent guidelines from the World Health Organization and European Medicines Agency aim to address the quality control of herbal drugs. This study focuses on the standardization of a coded poly-herbal tablet formulation and proposes a monograph for its quality control. The research provides valuable insights for pharmacists in formulating the product and can serve as a pharmaceutical standard operating procedure.