Nghiên cứu xây dựng quy trình định lượng silymarin trong viên bao đường chứa cao khô quả cúc gai bằng phương pháp HPLC

The aim of this work is to develop and validate a reverse-phase liquid chromatographic method with isocratic elution for determination of silymarin in a sugar coated tablet. The proposed HPLC method utilized a Gemini C18 column (25 cm × 4.6 mm, 5 μm) with UV detection. Standards and sample were dissolved in methanol. The method was validated as per ICH guidelines, a good linearity was observed in the concentration range of 7.0 – 350.0 µg·mL-1with a correlation coefficient (r) of more than 0.999. The RSD of intra-and inter-day precision variations were less than 1.5 % and the mean recovery was (99.65 ± 0.95)% (RSD = 0.95 %). The developed quantitative method was adequate for its purpose and could be applied for quality control of tablets containing powdered milk thistle extract.
Keywords: Silymarin, sugar coated tablet, powdered milk thistle extract, silybin, liquid chromatography.