Glantreo Limited, ERI Building, Lee Road, Cork City, Ireland; School of Chemistry, University College Cork, Cork, Ireland.
Glantreo Limited, ERI Building, Lee Road, Cork City, Ireland.
J Pharm Sci. 2021 Aug;110(8):3091-3098. doi: 10.1016/j.xphs.2021.03.028. Epub 2021 Apr 20.
For the first time, a simple and robust HPLC method has been developed for dissolution studies for cannabidiol (CBD) in hemp oil products. An isocratic elution of samples performed on SOLAS™ C18 150 mm x 4.6 mm, 5 μm column with a mobile phase consisting of 75:25 acetonitrile-water v/v, delivered at a flow rate 1.5 mL/minutes to variable wavelength detector using 214 nm. An in-house validated assay test was executed for calculating the purity of hemp oil products and also for considering the dissolution medium to be used. For dissolution studies, equivalent of 5 mg and/or 10 mg of the active was introduced into 500 mL of simulated gastric and intestinal fluids separately, and dissolution was performed at 50 rpm using paddles for 180 min. Dissolution profiles for hemp oil products purchased from the United States and Europe were compared. Additionally, dissolution testing was conducted to study the effect of percentage CBD release on increased agitation speed of 75 and 100 rpm and also, on extended dissolution runtime of 240 min.
首次开发了一种简单而强大的 HPLC 方法，用于大麻油产品中大麻二酚 (CBD) 的溶出度研究。在 SOLAS™ C18 150mm x 4.6mm，5μm 柱上进行等度洗脱，流动相由 75:25 乙腈-水 v/v 组成，以 1.5mL/min 的流速输送至可变波长检测器，使用 214nm。执行了内部验证的分析测试，用于计算大麻油产品的纯度，并考虑要使用的溶解介质。对于溶出度研究，将相当于 5mg 和/或 10mg 的活性成分分别引入 500mL 模拟胃液和肠液中，在 50rpm 下使用桨叶进行 180min 的溶出度试验。比较了从美国和欧洲购买的大麻油产品的溶出曲线。此外，还进行了溶出度试验，以研究增加搅拌速度 75 和 100rpm 以及延长 240min 的溶出时间对 CBD 释放百分比的影响。
