Development and application of a chemical profiling method for the assessment of the quality and consistency of the Pelargonium sidoides extract

Abstract

Abstract The evaluation of chemical similarity is very significant for the evaluation and standardization of the quality of herbal medicines as the biological activity of herbal medicines depends on the composition and proportion of many individual components. Many health organizations have recommended chemical profiling for the quality and consistency evaluation of herbal medicines. In this study, chemical profiling was performed to evaluate the similarity between batches of Pelargonium sidoides maltodextrin mixture (PMM) from EPs® 7630, a Pelargonium sidoides extract preparation. For chemical profile analysis, 7 common peaks were selected from 27 different PMM batches and specificity, linearity, accuracy, and precision tests were performed to develop the analytical method. The Pearson correlation coefficients of the similarity for all 27 batches manufactured over the years were higher than 0.90, indicating that quality consistency is well ensured over the years. This profiling method confirms the chemical profile of various commercial products using not only PMM but also Pelargonium sidoides extract and shows that it can be applied to standardization of quality.

Keywords

• Chemical profile
• Quality consistency
• Pelargonium sidoides
• EPs® 7630
• PMM
• HPLC