Abstract
Background—The quality control (QC) for commercial herbal formulations is sparse due to a lack of well-developed HPLC-ESI-MS/MS methods. Objective—This study reports the quantification of nine selected analytes for a commercial eight-herb formulation known as Qi Ju Di Huang Wan (QJDHW) used to relieve hypertension. Methods—An HPLC-ESI/MS method for the quantitation of analytes selected using the Herbal Chemical Marker Ranking System (Herb MaRS) was developed. The Herb MaRS ranking system which takes into account bioavailability, bioactivity, and physiological action related to its intended use and the commercial availability of the standard. After a method optimization, seven analytes were found to be ideal for quantitation. Results—The target analytes were identified using an electrospray ionization-tandem MS molecular breakdown comparison between the herbal peak and the commercial standard. The quantitative aspect of analyte variability of eleven samples was studied using fold variation. The fold variation of selected analytes among eleven samples ranged from 1.5 to 28.9. The qualitative aspect of variability was studied using principal component analysis (PCA) and hierarchical cluster analysis (HCA). Conclusions—There is a great degree of chemical variability in herbal formulations which are due to raw material harvesting times, storage techniques, and plant subspecies variability. Highlights—Commercial QJDHW formulations need to be standardised using HPLC-ESI-MS/MS to ensure better product quality control (QC) and product efficacy for the consumer.
Highlights
There has been a significant increase in the use and consumption of complementary medicines from traditional herbal sources in recent years
It is important for these types of manufactured formulas to have a standardised procedure for quality control (QC) in order to ensure the efficacy of the product [1,2,3,4,5,6]
The 50% spiking level shows lower recoveries than the 100% and 200% spiking levels. This was due to a constant loss of the analytes caused by the staining of analyte to the glass volumetric flask used in the analyses
Summary
There has been a significant increase in the use and consumption of complementary medicines from traditional herbal sources in recent years. The method validation of phyto-markers has been the industry standard for the quality control of medicinal herbal products. This often involves the quantitation of one or two analytes to assess the chemical variability of a commercial herbal product. The quality control (QC) for commercial herbal formulations is sparse due to a lack of well-developed HPLC-ESI-MS/MS methods. Methods—An HPLC-ESI/MS method for the quantitation of analytes selected using the Herbal Chemical Marker Ranking System (Herb MaRS) was developed. The quantitative aspect of analyte variability of eleven samples was studied using fold variation.
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