A novel HPLC method was developed and validated to simultaneously determine curcuminoids and dasatinib in a new dosage form. Excellent separation was achieved for a curcuminoids mixture and dasatinib with a ZORBAX Eclipse Plus Phenyl–Hexyl column (4.6 × 250 mm, 5 µm) and a mobile phase consisting of aqueous solution (0.2% acetic acid and 0.1% trifluoroacetic acid with the pH adjusted to 3.5) and acetonitrile with a gradient elution at a flow rate of 1 mL/min. The separated peaks were detected at 325 nm for dasatinib and 420 nm for the curcuminoids mixture. The mixture was separated in less than 20 min. The retention times were 6.5 min, 16.4 min, 17.5 min, and 18.4 min for dasatinib, bisdesmethoxycurcumin, desmethoxycurcumin, and curcumin, respectively. The linear range for all compounds was 0.5–140 µg/mL with a limit of detection of 0.10–0.50 µg/mL. The method was validated according to the International Council for Harmonization guidelines and was shown to be sensitive, fast, robust, specific, and accurate. The developed method was successfully applied to determine dasatinib and curcuminoids in a nanoparticle preparation with good accuracy and precision. The method may be utilized to conduct in vitro studies for new pharmaceutical formulations containing a similar combination of compounds.

中文翻译：

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使用新型 HPLC 方法同时分析基于 pluronic 的纳米颗粒制剂中的达沙替尼和类姜黄素

开发并验证了一种新的 HPLC 方法，以同时测定新剂型中的姜黄素和达沙替尼。使用 ZORBAX Eclipse Plus Phenyl-Hexyl 色谱柱（4.6 × 250 mm，5 µm）和由水溶液（0.2% 乙酸和 0.1% 三氟乙酸组成，pH 已调节）的流动相实现了姜黄素混合物和达沙替尼的出色分离至 3.5) 和乙腈，以 1 mL/min 的流速梯度洗脱。达沙替尼在 325 nm 处和姜黄素混合物在 420 nm 处检测到分离的峰。混合物在不到 20 分钟内分离。达沙替尼、双去甲氧基姜黄素、去甲氧基姜黄素和姜黄素的保留时间分别为 6.5 分钟、16.4 分钟、17.5 分钟和 18.4 分钟。所有化合物的线性范围为 0.5–140 µg/mL，检测限为 0.10–0。50 微克/毫升。该方法根据国际协调委员会的指导方针进行了验证，并显示出灵敏、快速、稳健、特异和准确。所开发的方法成功地用于测定纳米颗粒制剂中的达沙替尼和姜黄素，具有良好的准确度和精密度。该方法可用于对含有类似化合物组合的新药物制剂进行体外研究。