建立并验证纳米胶束载姜黄素的反相高效液相色谱法并应用于体内药代动力学研究。

Development and validation of RPâ€"HPLC method for estimation of curcumin from nanocochleates and its application in inâ€"vivo pharmacokinetic study.

出版信息

Acta Chim Slov. 2020 Dec;67(4):1100-1110.

Abstract

A reliable RP-HPLC analytical method with UV detection at 421 nm was developed and validated for the quantitative determination of curcumin from rat plasma after oral administration of curcumin loaded nanocochleates (CU-NC) to rats. The chromatographic separation was performed on HIQ SIL, C18 (250 mm × 4.6 mm) column using methanol and water (80:20 v/v) as mobile phase, at 1.0 mL/min flow rate. Validation parameters included linearity, accuracy, precision, and limit of quantitation and detection. Good linearity was obtained over the range of 2.5-100 µg/mL (R2 = 0.9979) of curcumin. The developed HPLC method was precise, with <2% relative standard deviation. Accuracy, stability, and robustness studies were also found to be acceptable. Bland-Altman plot showed an acceptable repeatability coefficient. The method was under statistical control, revealed by a control chart. After CU-NC administration, pharmacokinetic parameters i.e. Cmax, AUC0-?, and AUMC0-?, were observed to be 97.69±10.84 µg/mL, 1402.77±9.67 (µg/mL)×h, and 35140.16±14.67 (µg/mL)×h2, respectively. This simple and precise method can be effectively implemented for routine analysis.

摘要

建立并验证了一种可靠的反相高效液相色谱法（RP-HPLC），采用紫外检测法（UV），于 421nm 波长处对大鼠口服载姜黄素纳米螺内酯（CU-NC）后大鼠血浆中的姜黄素进行定量测定。采用 HIQ SIL，C18（250mm×4.6mm）柱，以甲醇和水（80:20v/v）为流动相，流速为 1.0mL/min，进行色谱分离。验证参数包括线性、准确度、精密度和定量限及检测限。姜黄素在 2.5-100µg/mL（R2=0.9979）范围内具有良好的线性。所建立的 HPLC 方法精密度良好，相对标准偏差小于 2%。准确度、稳定性和耐用性研究也被认为是可以接受的。Bland-Altman 图显示可接受的重复性系数。该方法处于统计控制之下，这一点通过控制图得以体现。在 CU-NC 给药后，观察到 Cmax、AUC0-?和 AUMC0-?等药代动力学参数分别为 97.69±10.84µg/mL、1402.77±9.67（µg/mL）×h 和 35140.16±14.67（µg/mL）×h2。该方法简单、准确，可有效用于常规分析。