Determination of fingerprint by Hplc-Uv of improved traditional medicines to combat the marketing of substandard and falsified medicines

Abstract

Improved traditional medicines (ITMs) are increasingly used worldwide, but quality control still poses challenges due to the lack of official analytical methods. This makes it impossible to guarantee their quality, efficacy, and safety. The primary aim of this study was to develop an analytical method using High-Performance Liquid Chromatography (HPLC) to characterise the chemical profiles of improved traditional medicines (ITMs) marketed in the Democratic Republic of Congo. This was followed by the validation of the developed method and its routine application. Chromatographic separation was performed using the XBridge C18 column (250 × 4.6 mm internal diameter; 5 µm particle size), maintained at 25°C. The mobile phase consisted of a gradient mixture of mobile phases A (acetonitrile) and B (0.05% aqueous trifluoroacetic acid solution), pumped at 1.0 mL/min. UV detection was carried out at 220 nm. A generic method was developed that proved to be specific, linear (R² > 0.990), accurate (RSD < 10%), and precise. The validated method was successfully applied to 12 real samples marketed in Kinshasa (capital of DR Congo). The validated HPLC method proves to be a reliable tool for ITM quality control. This method allows for the simultaneous analysis of multiple biomarkers in an ITM. Its routine use would support the harmonization and safety of these plant-based products, which are widely utilized in the DRC, and encourage scientifically supervised traditional medicine.