Development of dissolution test for the capsule of Thunbergia laurifolia

Thunbergia laurifolia Lindl. is a widely growing herb in Thailand. The leaves of T. laurifolia are indicated in the Thai national list of essential medicines 2018 for treating fever and relieving mouth ulcers. The dissolution method for evaluating caffeic acid and rosmarinic acid release from T. laurifolia leaf extract capsules was established in this study. The dissolution method was developed by testing the solubility of caffeic acid and rosmarinic acid from the leaf extract in 0.1 N HCl and water, as well as the influence of rotation speed. The dissolution method was then validated in accordance with the United States Pharmacopeia 2023. The results showed that the optimal dissolution for T. laurifolia capsules was achieved in 500 mL of 0.1 N HCl in water using apparatus 2 (a paddle) at a 100 rpm rotation speed at 37.0±0.5°C. Parameters including specificity, linearity, accuracy, precision and robustness were evaluated for the validation of the HPLC method, and the obtained results were acceptable according to the official criteria. The developed method was then used to evaluate the dissolution profiles of caffeic acid and rosmarinic acid released from the T. laurifolia extract capsule. The dissolutions of both chemical markers were higher than 85% at the 30-minute time point. The developed method could be useful for routine quality control of phytopharmaceutical products at the industrial level, especially for quality control of T. laurifolia leaf extract capsules in the future.

 

MissingLinkText

Publication History

Article published online:
16 November 2023