Phytochemical profiling of Balarista formulation by GC-MS analysis

Area of Science:

• Pharmacognosy
• Analytical Chemistry

Background:

• Balarista formulations are used therapeutically.
• Quality control of herbal formulations is crucial for ensuring safety and efficacy.

Purpose of the Study:

• To analyze the chemical composition of in-house and marketed Balarista formulations using Gas Chromatography-Mass Spectrometry (GC-MS).
• To identify and quantify key active metabolites, particularly benzoic acid, in different formulation fractions.
• To assess the potential impact of identified compounds, such as benzoic acid, on the therapeutic efficacy.

Main Methods:

• GC-MS analysis was performed on various fractions (n-hexane, ethyl acetate, methanol) of in-house Balarista formulation (IBF) and four marketed Balarista formulations (M1-M4).
• The National Institute of Standards and Technology (NIST) library was utilized for compound identification.
• Quantification of predominant compounds, including benzoic acid, was determined in different fractions.

Main Results:

• Benzoic acid was identified as a predominant compound in multiple fractions of marketed Balarista formulations (M2, M3, M4), with concentrations up to 94.69%.
• Other significant compounds detected include Hexan-2-ol, 3,3-Bis(4-hydroxy-3-methylphenyl)-1H-indol-2-one, 5-(Hydroxymethyl)furan-2-carbaldehyde, Propan-2-ol, 1,3,3-Trimethyl-2-oxabicyclo[2.2.2]octane, and (2R,3S,4S,5R,6R)-2,3,4,5,6,7-Hexahydroxyheptanal.
• The presence of high concentrations of benzoic acid suggests the indiscriminate use of sodium benzoate, quantified as benzoic acid equivalents.

Conclusions:

• The chemical profiling of Balarista formulations highlights significant variations in metabolite composition.
• The high levels of benzoic acid detected in marketed formulations raise concerns regarding potential adulteration or overuse of preservatives.
• Further investigation is warranted to understand the implications of these findings on the safety and therapeutic effectiveness of Balarista formulations.