Quantification of the Active Pharmaceutical Product (API) in a finished product is vital to ensure the end consumer gets the correct dosage of the drug. Too little and the desired effect may not be achieved, too much and an overdose is given, in the worst case resulting in death. FTIR affords a rapid cheap method for the routine testing of a wide range of pharmaceuticals. Read on to discover how we have used it to quantify Simeticone in formulations acquired on the UK high street…
According to the United Kingdom’s National Health Service, Simeticone is an over-the-counter medication for relief of excess wind, particularly taken by those with Irritable Bowel Syndrome, or to treat colic in babies. It is generally recognised as safe [1] but finds many uses in Pharmacopoeia due to its anti-foaming properties, and may even be administered prior to endoscopy examinations to reduce the bubbles and foaming in the gastrointestinal tract [2]. Different Pharmacopoeia standards will provide thresholds for safe use in medicines, which requires the ability to measure concentrations, molecular weight, and viscosity, among other parameters [2] and there will also be standards defining the proper labelling of these compounds, such as CFR Title 21, Volume 5, Part 332 in the USA.
The European Pharmacopoeia standard 10.0 (01/2017:1470) defines a method for the extraction of simeticone into an organic, toluene phase, which can then be measured by FTIR spectra in a 500 micron liquid transmission cell and quantified by comparison to a stock standard solution of known concentration. In order to demonstrate the suitability of the Pearl for use with this method we obtained two different formulations of simeticone available on the high street, and measured their %API content by reference to a standard simeticone sample of known concentration.
Our results were found to be in good agreement with the stated dosage on the label, confirming the validity of the method, and the suitability of the PearlTM for use with this method. For any analytical testing laboratory the Pearl greatly simplifies the procedure for obtaining an FTIR spectrum of a liquid at a defined pathlength, with higher sample throughput benefits as a result.
simeticone, for 3 different formulations
Read our Application Note below to learn more:
References
- https://www.nhs.uk/medicines/simeticone/ (Accessed 12/07/2022)
- Review of Current Pharmaceutical Applications of Polysiloxanes (Silicones), Krystyna Mojsiewicz-Pieńkowska, Vijay Kumar Thakur and Manju Kumari Thakur, Handbook of Polymers for Pharmaceutical Technologies, (363–382), © 2015 Scrivener Publishing LLC
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