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反相高效液相色谱法测定大麻油中大麻二酚和四氢大麻酚含量的分析方法验证。

Analytical method validation for assay determination of cannabidiol and tetrahydrocannabinol in hemp oil infused products by RP-HPLC.

机构信息

Glantreo Limited, ERI Building, Lee Road, Cork, T23 XE10, Ireland.

School of Chemistry, University College Cork, Cork, T12 YN60, Ireland.

出版信息

Sci Rep. 2022 Jul 21;12(1):12453. doi: 10.1038/s41598-022-13737-6.

DOI:10.1038/s41598-022-13737-6
PMID:35864137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9304360/
Abstract

A simple quantitative reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for assay determination of cannabidiol and tetrahydrocannabinol in hemp oil infused products. The RP-HPLC method was developed and optimized for the mobile phase composition, flow rate, column selection and detector wavelength. An isocratic elution of samples were performed on SOLAS 100 Å C18 150 mm × 4.6 mm, 5 μm column with a mobile phase containing 75/25 acetonitrile/water v/v, with a flow rate of 1.5 mL/min by using an ultraviolet-visible (UV/Vis) detector operating at 214 nm. The RP-HPLC method was validated to meet regulatory requirements which covers specificity, accuracy, range, linearity, precision, system suitability and robustness. The validated assay test method was applied successfully to quantify cannabidiol and tetrahydrocannabinol in commercial hemp oil infused products such as tablets, soft gel capsules, plant extract oils, oral drops, tincture, and beverage enhancers. All the test results were found acceptable as per ICH guidelines, and this confirmed the feasibility of this method for its intended use in regular quality control and assay of cannabidiol and tetrahydrocannabinol in hemp oil infused products.

摘要

一种简单的反相高效液相色谱（RP-HPLC）定量方法已经开发并验证，用于测定大麻油注入产品中大麻二酚和四氢大麻酚的含量。RP-HPLC 方法是针对流动相组成、流速、柱选择和检测器波长进行开发和优化的。采用 SOLAS 100Å C18 150mm×4.6mm，5μm 柱，以 75/25v/v 的乙腈/水为流动相，流速为 1.5mL/min，在 214nm 处用紫外-可见（UV/Vis）检测器进行等度洗脱，对样品进行洗脱。RP-HPLC 方法经过验证，符合监管要求，涵盖专属性、准确性、范围、线性、精密度、系统适用性和耐用性。该验证后的分析测试方法成功应用于定量测定商业大麻油注入产品中的大麻二酚和四氢大麻酚，如片剂、软胶囊、植物提取物油、口服滴剂、酊剂和饮料增强剂。所有测试结果均符合 ICH 指南要求，这证实了该方法在常规质量控制和大麻油注入产品中大麻二酚和四氢大麻酚分析中的应用可行性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/b1db04101b1c/41598_2022_13737_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/b81bd1ea16ce/41598_2022_13737_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/ed926c78bee5/41598_2022_13737_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/77436265dbea/41598_2022_13737_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/a866d712aecc/41598_2022_13737_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/93c9b3e7dadb/41598_2022_13737_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/b1db04101b1c/41598_2022_13737_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/b81bd1ea16ce/41598_2022_13737_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/ed926c78bee5/41598_2022_13737_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/77436265dbea/41598_2022_13737_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/a866d712aecc/41598_2022_13737_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/93c9b3e7dadb/41598_2022_13737_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cbe/9304360/b1db04101b1c/41598_2022_13737_Fig6_HTML.jpg

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