title: Quality control assessment of polyherbal formulation based on a quantitative determination multimarker approach by ultra high performance liquid chromatography with tandem mass spectrometry using polarity switching combined with multivariate analysis.
abstract: An ultra high performance liquid chromatography with electrospray ionization tandem mass spectrometry method has been developed and validated for the simultaneous quantification of 28 major bioactive compounds in Mentat tablet, a complex Indian herbal medicine used in the treatment of neurological disorder and improvement of mental health. Multiple-reaction monitoring scanning was employed for quantification in positive and negative ion switching mode. The analysis was accomplished on Waters ACQUITY UPLC BEH C18column with linear gradient elution of water/formic acid (0.1%) and acetonitrile/formic acid (0.1%) at a flow rate of 0.3 mL/min. The proposed method was validated with acceptable linearity (r2, 0.9984-0.9999), precision (RSD, 0.22-2.11%), stability (RSD, 0.16-1.78%), and recovery (RSD ≤ 3.74%), under optimum conditions. The limits of quantitation ranged from 0.28 to 3.88 ng/mL. The method was successfully applied for simultaneous determination of 28 compounds in 20 batches of Mentat tablet. Hierarchical cluster analysis and principal component analysis were performed to evaluate the similarity and variation of the 20 samples based on the characteristics of 28 bioactive compounds. Results indicated that this method is rapid, sensitive, and reliable to show the quality of the Mentat tablet's composition, hence may be used for quality control of polyherbal formulations having similar markers/raw herbs.
authors.affiliation: Sophisticated Analytical Instrument Facility, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, India.|Academy of Scientific and Innovative Research (AcSIR), New Delhi, India.
authors.forename: Preeti
authors.initials: P
authors.lastname: Chandra
authors.affiliation: Sophisticated Analytical Instrument Facility, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, India.|Academy of Scientific and Innovative Research (AcSIR), New Delhi, India.
authors.forename: Renu
authors.initials: R
authors.lastname: Pandey
authors.affiliation: Academy of Scientific and Innovative Research (AcSIR), New Delhi, India.|Biometry and Statistics Division, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
authors.forename: Mukesh
authors.initials: M
authors.lastname: Srivastva
authors.affiliation: Sophisticated Analytical Instrument Facility, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, India.|Academy of Scientific and Innovative Research (AcSIR), New Delhi, India.
authors.forename: Brijesh
authors.initials: B
authors.lastname: Kumar
keywords: Hierarchical cluster analysis; Multimarker quantification; Multiple reaction monitoring; Polyherbal formulation; Principle component analysis