Development and Validation of Dissolution Test Method for Herbal Medicine Containing Ginsenosides

Abstract

Background and objective: This study aimed to develop a dissolution test method for quality control of commercial 40% ethanol extract of ginseng-containing dosage forms.Methods: Through preliminary dissolution testing of the commercial dosage forms, suitable parameters for HPLC (high performance liquid chromatography) analysis were determined, including an injection volume of 50 μL and a dissolution time of 1 hour. Additionally, the stability testing of the solution enabled the selection of an appropriate dissolution medium, pH 4.0 buffer solution. Method validation was carried out using reference standard of eight ginsenosides (Rg1, Re, Rf, Rg2, Rb1, RC, Rb2, Rd), indicative components of ginseng, under the selected testing conditions. The evaluation of method validation encompassed specificity, accuracy, precision, and linearity as assessment criteria.Results: The accuracy assessment revealed that the average recovery rates within a 95% confidence interval were appropriate for all ginsenosides, ranging from 98.25% to 101.17%. The precision evaluation, conducted at an intermediate concentration of 8 μg/mL (n = 6), demonstrated relative standard deviations of 0.25% to 1.08%, which met the criterion of being below 2%. The linearity assessment showed that the coefficient of determination (R²) values for all ginsenosides exceeded 0.999, indicating excellent linearity. The quantification limits ranged from 0.32 to 1.09 μg/mL, confirming their suitability for dissolution assessment of the respective formulation. Employing the selected dissolution test method, the dissolution profiles of most ginsenosides in the commercially available ginseng-containing dosage forms reached their maximum values within 60 minutes. No significant differences were observed in results beyond 120 minutes, confirming that a dissolution time of 60 minutes is appropriate for this dosage form.Conclusion: The established method holds promise as a valuable tool for quality control of pharmaceuticals containing ginseng, including those previously unassessed, contributing to future applications in the pharmaceutical industry.