Determination of the amount of simethicone in different drug formulations by the gravimetric method and comparison with the ftir method by chemometric methods Guleli Muge1, Issever Sezin1, Caliskan Cem2,*, Ozbek Mahmut1 1World Medicine Pharmaceutical Industry and Trade Inc. R&D Center, 15 Temmuz Mah. Cami yolu Cad. No:50 K:4 Gunesli, Istanbul, Turkey 2Department of Chemistry, Yildiz Technical University, Davutpasa Campus, 34220, Esenler, Istanbul, Turkey *Corresponding Author E-mail: cem.caliskan@worldmedicine.com.tr
Online published on 27 April, 2021. Abstract Fourier transform infrared (FTIR) spectroscopy was mostly used in both pharmacopeia and literature studies to determine the assay of simethicone (SMT) in pharmaceuticals. It should be noted that HPLC is used less frequently. As an alternative to the mentioned methods, a new, simple, fast, easy-to-apply and very cheap gravimetric method was developed and validated according to ICH guidance entitled Q2B Validation of Analytical Procedures: Methodology for the quantification analysis of simethicone in different pharmaceutical forms. For the simethicone suspension product provided to alleviate too much gas in the gastrointestinal tract, the simethicone amount was determined both by the validated gravimetric method and by the FTIR method defined in the USP and BP monographs, and the results were within the acceptance criteria. It is emphasized that there is no significant difference between the results of gravimetric and FTIR methods according to the calculated F- and t-test results. Top Keywords Simethicone, Gravimetric method, F- and t-test, Method validation, Assay. Top |