Abstract

The present work aims at developing a QbD assisted RP-HPLC method for the estimation of individual curcuminoids in Curcuma longa rhizomes along with its quality assessment. The quality of crude C. longa sample was evaluated with respect to physicochemical, phytochemical and toxic contaminant analysis. The ATP and CQA’s were identified followed by the optimization of the method by employing 2² factorial design. The concentration of orthophosphoric acid in aqueous phase (X₁) and mobile phase ratio (X₂) were selected as independent variable whereas, Tailing factor CUR (R₁), peak width CUR (R₂), Tailing factor DMC (R₃), peak width DMC (R₄), Tailing factor BDC (R₅), and peak width BDC (R₆) selected as dependent variables. The optimized chromatographic conditions were identified with mobile phase, Acetonitrile and Water (0.02%OPA) in the ratio of 55:44 with flow rate of 1 mL/min and detection wavelength of 425 nm. Further, the amount of curcumin, demethoxycurcumin and bis-demethoxycurcumin in crude C. longa sample was found to be 13.86 ± 0.28, 10.98 ± 0.23 and 9.32 ± 0.20 mg/g respectively. From the results obtained it can be concluded that the application of the QbD approach ensured the development of a more precise method that can engender consistent, reliable, and quality data throughout the process and also save time.

摘要

本工作旨在开发一种QbD辅助RP-HPLC方法，以评估姜黄根茎中的单个姜黄素类化合物及其质量。在理化，植物化学和毒性污染物分析方面评估了粗制长龙眼样品的质量。确定ATP和CQA，然后采用2 ²因子设计优化方法。选择水相中正磷酸的浓度（X ₁）和流动相比（X ₂）作为自变量，而尾矿因子CUR（R ₁），峰宽CUR（R ₂），尾矿因子DMC（R _3）），峰宽DMC（R ₄），拖尾系数BDC（R ₅）和峰宽BDC（R ₆）作为因变量。流动相，乙腈和水（0.02％OPA）的比例为55:44，流速为1 mL / min，检测波长为425 nm，可以确定最佳的色谱条件。此外，发现粗制长形假丝酵母样品中姜黄素，去甲氧基姜黄素和双去甲氧基姜黄素的含量分别为13.86±0.28、10.98±0.23和9.32±0.20 mg / g。从获得的结果可以得出结论，QbD方法的应用确保了更精确方法的开发，该方法可以在整个过程中产生一致，可靠和高质量的数据，并且可以节省时间。