NGHIÊN CỨU XÂY DỰNG VÀ THẨM ĐỊNH PHƯƠNG PHÁP ĐỊNH LƯỢNG ANDROGRAPHOLID TRONG HỆ NANO POLYME BẰNG PHƯƠNG PHÁP SẮC KÝ LỎNG HIỆU NĂNG CAO

Abstract

Objectives: To develop and validate a high performance liquid chromatography method for the quantification of Andrographolid in polymeric nanosystem. Methods: Surveying chromatographic conditions validating quantification method, according to ICH guidelines in terms of system suitability, specificity, linearity, precision, accuracy, limit of detection, and limit of quantification. Results: The chromatographic conditions were determined. The quantitative method shows a close linear correlation between the peak area and Andrographolide concentration in the range of 5 - 30 µg/mL with regression correlation coefficient R² = 0.9981, good repeatability with RSD = 0.1492%, good accuracy of 99.91 - 102.77%. The limit of detection is 0.4 µg/mL and the lower limit of quantification is 1.2 µg/mL. Conclusion: A high-performance liquid chromatography method has been developed to quantify Andrographolide in polymeric nanosystems, serving as a basis for further studies.