Therapeutic Categorization and Physicochemical Profiling of Proprietary Ayurvedic Herbal Capsules Marketed in India

Abstract

The present study evaluated 99 marketed herbal capsule formulations across diverse therapeutic categories, including musculoskeletal health, renal care, dermatology, diabetes, gastrointestinal disorders, cardiac wellness, immunity, respiratory support, sexual health, neurological function, women’s health, and hepatobiliary care. Representative products were grouped into 14 categories, with recurring botanicals such as Withania somnifera, Tinospora cordifolia, Emblica officinalis, Commiphora mukul, and classical poly-herbal constructs like Triphala and Trikatu.

Physicochemical analysis revealed wide variability in pH (1.05–9.29; mean 5.02 ± 1.38), water-soluble matter (WSM: 3.4–96.44%; mean 50.81 ± 23.01%), and alcohol-soluble matter (ASM: 2.6–94.8%; mean 28.25 ± 16.42%), reflecting heterogeneity in raw material quality, extraction efficiency, and formulation practices. Statistical correlation indicated a moderate positive relationship between WSM and ASM (r = 0.324, R² = 0.105, p < 0.01), suggesting partial overlap in phytochemical solubility but underscoring the need for solvent-specific quality assessment.

TLC profiling demonstrated significant variation in Rf values and spot distribution, highlighting inconsistencies in phytochemical composition and lack of standardized marker validation.

Ayurvedic principles provided interpretative insights into solubility and pH variability, linking physicochemical parameters with traditional concepts of Rasa, Guna, Virya, and Vipaka.

Collectively, the findings emphasize poor label transparency, substantial physicochemical variability, and inconsistent TLC fingerprints, raising concerns about therapeutic predictability and reproducibility. Proposed standard ranges (pH 4.0–7.0; WSM 40–80%; ASM 15–35%; TLC 3–8 spots) underscore the need for stricter regulatory oversight, standardized extraction protocols, and incorporation of quantitative phytochemical markers to ensure quality, safety, and efficacy of herbal capsule formulations.