Development and Validation of a Green Stability-Indicating HPTLC Method for Estimation of Curcumin, Gallic Acid, and Ursolic Acid From Polyherbal Formulation Jatyadi Taila.

Abstract

Jatyadi taila (JT) is a well-known Ayurvedic wound-healing product, comprising 16 different medicinally important plants, including Curcuma longa, Terminalia chebula, and Jasminum officinale. The proposed work discusses the development and validation of the green and economical stability-indicating HPTLC method for quantification of the key marker phytoconstituents, curcumin (CUR), gallic acid (GA), and ursolic acid (UA), from JT. Quality standard parameters for JT were determined following standard procedures. The marker constituents CUR, GA, and UA were resolved from JT using toluene-ethyl acetate-formic acid (6:2:1, v/v/v) as the mobile phase and subsequently derivatized to estimate UA. The developed plates were subjected to HPTLC-MS analysis. All constituents were subjected to forced degradation to determine the proposed technique's stability-indicating property and the accelerated stability studies of marketed formulation and marker constituents. Greenness evaluation of the method was aided by the AGREE methodology. The Rf values of CUR, GA, and UA were found to be 0.60 and 0.60; 0.27 and 0.28; and 0.74 and 0.77 from reference standard and oil samples respectively, when analyzed at 366 nm, 290 nm, and 366 nm, respectively. HPTLC-MS was carried out to verify the active constituents present in JT. The constituents followed first-order degradation kinetics. The quantity of CUR, GA, and UA in JT was reduced at the end of accelerated stability studies. The developed approach was validated in compliance with the International Conference on Harmonization (ICH) Q2 (R2) guideline. Among the chosen key markers, GA was highly unstable during forced degradation. JT should be stored at a controlled temperature using more protective packaging material to ensure its quality and efficacy. The developed method can be used as a quality control tool for JT as it can be used to determine the stability of the key marker compounds the herbal formulation.