A Gas Chromatographic-Based Method for Determination of γ- terpinene in a herbal solid dosage form

Gastrointestinal reflux, as a physiologic process, commonly occurs following a daily meal with no sign. But in pathologic condition, it may be accompanied by some complications such as heartburn. In Traditional Persian Medicine (TPM), Heartburn has been defined as “Harghat-e-me’adeh” or “Josha-e-hāmez”. There are many formulations for the management of this complication in TPM. Current work aimed to reformulate and standardized a multi-ingredient preparation from Qarabadin textbooks of Persian medicine, containing True cardamom, Ginger, Black cumin and Mastic. Following content authentication and microscopic characterization, various tablet formulations were prepared using related excipients. The final formulation was a tablet containing those ingredients, with avicel and Magnesium stearate. Subsequently, tablets were extracted via the hydrodistillation method to yield the essential oil. Chemical composition analysis of essential oil was carried out using Gas Chromatography/Mass spectrometry apparatus (GC/MS). α-terpinyl acetate (34.02%), 1,8- cineole (18.07), cumin-aldehyde (8.15), and γ-terpinene (11.74%) were identified as major constituents. The content determination of tablets was performed via Gas Chromatography/Flame ionization detector (GC/FID). Data on pharmaceutical assessment included friability (less than 1%), weight variation (less than 1%), hardness (6.5±0.5 kg/cm^2), disintegration time (less than 35 min) and thickness (3.02±.04 mm). The yield of essential oil extracted from the tablet was found 3%, and each tablet contained 1.33 mg γ-terpinene. This finished product can be introduced as medicine for the clinical trial and pharmaceutical industry.