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

Document Type: Research article

Authors

1 Phytochemistry Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Department of Medicinal Chemistry, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Department of Chemistry, Richardson College of the Environmental Science Complex, The University of Winnipeg, Winnipeg, Canada

4 Incubation Center for Pharmaceutical Technologies, Shahid Beheshti University of Medical Sciences

5 Department of Chemistry, Richardson College of the Environmental Science Complex, The University of Winnipeg, Winnipeg, Canada.

Abstract

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-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 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.

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