HPLC method development and validation for quantitation of CBD and THC in Suk-SaiYas Pills

Pathamaporn Pathompak; Natawat Chankana; Nirun Vipunngeun; Somporn Phonkrathok

Authors

Pathamaporn Pathompak Drug and Herbal Product Research and Development Center, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand
Natawat Chankana Sun Herb Thai Chinese Manufacturing, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand
Nirun Vipunngeun Department of Pharmacognosy, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand
Somporn Phonkrathok College of Oriental Medicine, Rangsit University, Pathum Thani 12000, Thailand

Keywords:

CBD, HPLC, method validation, pills, Suk-SaiYas recipe, THC

Abstract

The Suk-SaiYas recipe is one of the oldest Thai medicinal recipes recorded for insomnia treatment. This recipe comprises 12 herbal medicinal plants, of which cannabis is the major active pharmaceutical ingredient. Recently, traditional medicine has been widely used by many patients. To ensure the therapeutic property of Suk-SaiYas pills, a standard analytical method for measuring the active compound should be identified. This research aims to develop and validate the HPLC method following ICH guidelines to quantify CBD and THC in Suk-SaiYas pills. The chromatographic separation was accomplished using step-gradient elution on the ZORBAX Eclipse Plus C18 (4.6 x 100 mm, 3.5 µm) column at 30^oC. Acetonitrile and water were used as mobile phases with a 0.5 ml/min flow rate. CBD and THC exhibited a linear relationship in the concentration range of 0.25 - 10.0 µg/ml with R² > 0.9998. The repeatability was less than 1%; the intermediate precision did not exceed 2% for both constituents. The average % recovery of two analytes ranged between 92 - 106%. The limit of detection and the limit of quantification was found to be 0.03 and 0.10 µg/ml, respectively. Finally, it may be concluded that the developed HPLC method is precise and accurate for the determination of CBD and THC contents and could be utilized for the quality control of Suk-SaiYas pills

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