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

• 영문명: Development and Validation of Dissolution Test Method for Herbal Medicine Containing Ginsenosides
• 발행기관: 인간식물환경학회
• 저자명: 이성훈(Sung-Hoon Lee)
• 간행물 정보: 『인간식물환경학회지(JPPE)』제26권 제6호, 793~803쪽, 전체 11쪽
• 주제분류: 자연과학 > 자연과학일반
• 파일형태: PDF
• 발행일자: 2023.12.31

영문 초록

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 (highperformance liquid chromatography) analysis were determined, including an injection volume of 50 μL and a dissolutiontime 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 methodvalidation encompassed specificity, accuracy, precision, and linearity as assessment criteria. Results: The accuracy assessment revealed that the average recovery rates within a 95% confidence interval wereappropriate for all ginsenosides, ranging from 98.25% to 101.17%. The precision evaluation, conducted at an intermediateconcentration of 8 μg/mL (n = 6), demonstrated relative standard deviations of 0.25% to 1.08%, which met the criterionof being below 2%. The linearity assessment showed that the coefficient of determination (R²) values for all ginsenosidesexceeded 0.999, indicating excellent linearity. The quantification limits ranged from 0.32 to 1.09 μg/mL, confirming theirsuitability for dissolution assessment of the respective formulation. Employing the selected dissolution test method, thedissolution profiles of most ginsenosides in the commercially available ginseng-containing dosage forms reached theirmaximum values within 60 minutes. No significant differences were observed in results beyond 120 minutes, confirmingthat 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 containingginseng, including those previously unassessed, contributing to future applications in the pharmaceutical industry.

목차

Introduction

Research Methods

Results and Discussion

Conclusion

References

키워드

panax ginseng meyer quality control analytical validation HPLC