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Cannabis oral drops is the Cannabis extract in a suitable vegetable oil. It contains Cannabinoids, including Delta-9-tetrahydrocannabinol (Delta-9-THC) and/ or Cannabidiol (CBD). It is used for the treatment of intractable epilepsy, spasticity, nausea and vomiting. In present, the analytical method for this product is unavailable in the official pharmacopoeia. Thus, Bureau of Drug and Narcotic was necessary to developed and validated the method for determination of Delta-9-THC and CBD in Cannabis extract and Cannabis oral drops by High Performance Liquid Chromatography (HPLC). The chromatographic separation was accomplished on C18, 4.6 x 150 mm reverse-phase column. The linear gradient solutions consisted of mobile phase (A) Ammonium formate pH 3.75 with 10% acetonitrile and (B) 90% acetonitrile. The flow rate was maintained at 1.0 mL/min. The analytes were monitored at 228 nm. This method was specificity. The linearity range was obtained from 2 to 100 mcg/mL. The % recovery of accuracy of Delta-9-THC and CBD were in the range of 86-99 and 94-102%, respectively. The %RSD of repeatability and intermediate precision (different instruments and days) were not more than 2.0. The standard solution and sample solution were stable for at least 2 days. This developed method is suitable to use as standard method of Thai Pharmacopoeia for determination of Delta-9-THC and CBD in Cannabis extract and Cannabis oral drops.

Keywords: Cannabinoids, Cannabis extract, Cannabis oral drops, HPLC