Development and Validation of a GC/MS Method for Simultaneous Determination of 7 Monoterpens in Two Commercial Pharmaceutical Dosage Forms

Terpenes are active constituents of many pharmaceutical dosage forms with naturalproducts origin. One of the challenges in developing dosage forms with herbal originis their standardization as pharmaceutical products. GC-Mass is the most decisive andreliable technique to fulfill the requirements in this regard. In the present study, a reliable,rapid, and accurate method was developed for determination of 7 monoterpenoids in twoselected pharmaceutical dosage forms (rowatinex and rowachol soft gelatin capsules) by gaschromatography-mass spectrometry triple quadrupole selected ion monitoring GC/MS-TQSIM.The method was validated for various parameters such as precision, linearity, accuracy,solution stability, limit of detection, and quantification. The average recovery of terpens wasin the range of 91.6-105.7%. The method was proved to be repeatable with RSD in the rangeof 0.28-11.18 for all of the concentration levels. The developed method is simple, rapid, andsensitive and was applied for determination of alpha pinene, camphene, beta pinene, cineol,fenchone, borneol, trans-anethol and menthol in a few batches of rowachol and rowatinexcapsules purchased from local drug stores.