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

摘要

Terpenes are active constituents of many pharmaceutical dosage forms with natural products origin. One of the challenges in developing dosage forms with herbal origin is their standardization as pharmaceutical products. GC-Mass is the most decisive and reliable 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 two selected pharmaceutical dosage forms (rowatinex and rowachol soft gelatin capsules) by gas chromatography-mass spectrometry triple quadrupole selected ion monitoring GC/MS-TQ-SIM. The method was validated for various parameters such as precision, linearity, accuracy, solution stability, limit of detection, and quantification. The average recovery of terpens was in the range of 91.6-105.7%. The method was proved to be repeatable with RSD in the range of 0.28-11.18 for all of the concentration levels. The developed method is simple, rapid, and sensitive 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 rowatinex capsules purchased from local drug stores.