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

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 performed on SOLAS™ 100 Å C18 150 mm x 4.6 mm, 5 µm column with a mobile phase containing 75/25 acetonitrile/water v/v, delivered at a flow rate 1.5 mL/minutes to an Ultraviolet – Visible (UV/Vis) detector using 214 nm. The RP-HPLC method was validated to meet regulatory requirements and 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 test results were found acceptable as per ICH guidelines, and this confirmed that the method is fit for its intended use in regular quality control and assay of cannabidiol and tetrahydrocannabinol in hemp oil infused products.