Method Development and Verification of Assay of Simethicone in Simethicone Soft Gel Capsule in the Form of Polydimethylsiloxane by FT-IR

In this research article, Fourier Transform Infrared (FT-IR) Spectroscopy method was developed for the determination of Assay of Simethicone in Simethicone Soft Gel Capsule. The method has been adopted from United States Pharmacopeia (USP). However, it could not produce precise results since different instruments and data acquisition software have wide range of instrumental/software parameters. Thus, the FT-IR method was developed using Shimadzu IR affinity instrument with Lab solution data acquisition software and verified according to ICH guideline Q2R(2) Validation of Analytical Procedure. The acceptance criteria for the determination of Assay of Simethicone in Simethicone Capsule liquid filled in the form of Polydimethylsiloxane is 85.0% to 115.0%.