Standardization and Quality Control Analysis of a Polyherbal Antidiabetic Formulation

Abstract

Exploration of novel drugs from natural resources may not always result in the effective management of complex metabolic conditions like diabetes using the “one disease, one therapy, and one target” paradigm. As a result, the field of synergistic pharmacology, which includes polyherbal medicines, has become the preferred method for discovering new pharmaceuticals. This study aims to standardize a polyherbal antidiabetic formulation by combining Costus pictus, Gymnema slyvestre, and Momordica charantia via synergism to enhance the bioavailability of the active compounds, reduce the toxicity and promote therapeutic effects of the selected herbs for antidiabetic activity. The formulation was standardized by evaluating its physical characteristics, powder characteristics, physicochemical properties, phytochemical properties, chromatographic analysis, fluorescence analysis, and safety parameters concerning toxins, microbes, and residues. The loss on drying was 8%, which was within the prescribed limits, indicating that the product has a long storage life. Inorganic metallic salts, such as silica and phosphates, are negligible in the powder, as indicated by its ash value (7.51%), acid-insoluble ash (1.07%), water-soluble ash (2.97%), and sulphated ash (7.76%). The extractive value of water was the highest (12.66%), compared to alcohol (3.54%) and ether (3.34%). The polyherbal formulation was acidic with pH of 6.5 and 6.0 in 1% and 10% solution, respectively, which minimizes the possibility of microbial contamination. The phytochemical analysis confirmed the presence of alkaloids, triterpenoids, flavonoids, phenols, saponins, glycosides, tannins, and diterpenes. Based on the safety evaluation results, the formulation is safe to consume and free of heavy metal contamination, microbial load, pesticide residue, and aflatoxin. The established metrics are sufficient for assessing polyherbal formulation and can be used as reference standards for quality control and assurance. The lack of standardization studies has hampered the translation of new drug candidates into commercially viable therapies, so standardized alternatives are imperative for determining safety, efficacy, and reliability.