Method Development and Verification of Assay of Simethicone in Simethicone Soft Gel Capsule in the Form of Polydimethylsiloxane by FT-IR
Chinmaykumar Oza
Chinmaykumar Oza, Analytical Chemist, Apnar Pharma LLP 10 Lake Drive, East Windsor (New Jersey), USA.
Manuscript received on 23 January 2025 | First Revised Manuscript received on 27 January 2025 | Second Revised Manuscript received on 16 March 2025 | Manuscript Accepted on 15 April 2025 | Manuscript published on 30 April 2025 | PP: 1-8 | Volume-5 Issue-3, April 2025 | Retrieval Number: 100.1/ijapsr.C407005030425 | DOI: 10.54105/ijapsr.C4070.05030425
Open Access | Editorial and Publishing Policies | Cite | Zenodo | OJS | Indexing and Abstracting
© The Authors. Published by Lattice Science Publication (LSP). This is an open-access article under the CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Abstract: 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%.
Keywords: FT-IR, ICH Guidelines, Assay, Simethicone, Soft Gelatin Capsule, Validation, Lab Solution Data Acquisition
Scope of the Article: Pharmaceutical Chemistry