Validated Stability-Indicating HPTLC Method for Determination of Bergenin in formulation with Forced Degradation Assessment

Ensuring uniform quality in polyherbal formulations is difficult due to their diverse phytochemical profiles. In the present work, a stability-indicating HPTLC approach was developed and validated to quantify bergenin in a GBD tablet, in line with International Council for Harmonization recommendations. Formic acid, methanol, ethyl acetate, and toluene (۳:۵:۲:۰.۱, v/v/v/v) were used for chromatographic separation, and densitometric detection at ۲۷۹ nm yielded a well-resolved peak at Rf ۰.۵۲ ± ۰.۰۲. The method showed excellent linearity over ۱۰۰–۵۰۰ ng/spot (R² = ۰.۹۹۹۴) with high sensitivity (LOD ۱۵.۵۲ and LOQ ۴۷.۰۴ ng/spot, respectively), along with acceptable accuracy and precision (%RSD < ۲). The assay confirmed bergenin content as ۱.۳۲ mg per tablet (۰.۱۲۵% w/w). Forced degradation studies indicated complete degradation under alkaline conditions, moderate degradation under acidic, oxidative, and UV stress, and minimal degradation under thermal and photolytic conditions, with a common degradant observed at Rf ~۰.۶۴. The developed method provided effective resolution of bergenin from its associated degradation products, confirming its suitability for polyherbal formulation quality control and stability evaluation.

کلیدواژه ها:

bergenin ، HPTLC ، Stability-indicating method ، Forced degradation ، Method Validation ، Polyherbal formulation