Development of Quality Standard and a Comprehensive Quality Control Study of Bharngyadi Kvatha Churna: An Ayurvedic Formulation

Abstract

Background: Bharngyadi Kvatha Churna (BKC) is an important polyherbal formulation mentioned in the Ayurvedic Formulary of India (AFI) for the treatment of intermittent fever and chronic fever but lacks the presence of standardised quality control parameters. Aims: The aim of the present study was to develop a quality standard of BKC and to carry out a comprehensive quality control study, including the evaluation of physicochemical parameters, safety parameters, elemental content, secondary metabolites, and selected phytochemical analysis. Methods: In HPTLC analysis, piperlongumine was quantified in BKC using a silica gel-coated aluminium plate and developing solvent of toluene: acetone (6:4 v/v). In HPLC analysis, piperine was quantified using acetonitrile: water (80: 20 v/v) mobile phase, and ellagic acid was quantified using water (0.05% KH2PO4): acetonitrile (70: 30 v/v) mobile phase. ICP-OES was used to determine elemental content. The estimation of secondary metabolites like total sugars, tannins, flavonoids, alkaloids, and saponins was also carried out using a UV-Vis spectrophotometer. The volatiles present in the volatile oil of BKC were analysed using the gas chromatography-mass spectrometry technique. Results: The physicochemical parameters namely, loss on drying, total ash, acid-insoluble ash, alcohol- soluble extractive, water-soluble extractive, pH (10% aq. susp.), and volatile oil ranged from 10.56% to 11.06%, 4.67% to 5.76%, 0.73% to 1.78%, 7.56% to 8.2%, 12.04% to 13.06%, 5.87% to 5.96%, and 0.091% to 0.097%, respectively. The amount of piperlongumine in BKC ranged from 0.7688 mg/g to 0.9902 mg/g. The amount of piperine and ellagic acid ranged from 0.1180% to 0.1362% and 0.0016% to 0.0034%, respectively. Oleyl alcohol is the major volatile phytochemical present in BKC. Conclusions: The developed standardised quality control parameters of BKC would aid the herbal industry in developing BKC with requisite quality.