ABSTRACT

Bacoside-A is a common biomarker of Bacopa Monnieri, a commonly used herb in Ayurvedic formulations for the treatment of various CNS disorders. Stability indicating RP-HPLC method for the estimation of bacoside-A (mixture of bacoside A3, bacopaside-II, jujubogenin (isomer of bacopasaponin-C) and bacopasaponin-C) from Bacopa Monnieri plant extract and its marketed formulation (tablets) was developed. The marker compound bacoside–A was resolved using mobile phase acetonitrile:phosphoric acid (30:70 v/v) with gradient elution on a C18 column at ambient temperature. The detection was performed at 205 nm. The pure bacoside-A, plant extract, and marketed formulation were subjected to forced degradation and accelerated stability studies. The developed RP-HPLC method was further validated as per ICH guidelines.The retention time was found to be 17.98,18.56,20.27,21.20min for four different peaks of bacoside A3, bacopaside-II, jujubogenin (isomer of bacopasaponin-C) and bacopasaponin-C respectively in standard bacoside-A, plant extracts, and tablets. The developed method can be used satisfactorily for the quantification of all four components in the presence of degradation products. Forced degradation study revealed that all components of bacoside-A was found to follow first-order kinetics during acidic and alkaline hydrolysis. The contents of all four components was reduced considerably at the end of accelerated stability studies in standard bacoside-A, plant extract, and tablets.It was concluded that moisture and pH play a pivotal role in maintaining the stability of Bacopa Monnieri formulations. The developed method can serve as a quality control tool to determines the effect of various environmental factors on the content of Bacoside-A in herbal and polyherbal formulations. Keywords: Bacopa Monnieri, Stability, Forced Degradation, Accelerated Stability, bacoside-A
Publication date: 01/01/2024

https://ijbpas.com/pdf/2024/January/MS_IJBPAS_2024_7349.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.1.7349