Designing Non-Invasive Quality Control Methods for ‎Pharmaceutical Drugs

Date

2024-3-11

Author

ALAM, Hani

Metadata

Show full item record

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Item Usage Stats

50
views

0
downloads

Cite This

The quality of pharmaceutical products is a critical aspect of the pharmaceutical industry that attempts to ensure that they meet the required safety and efficacy standards. Quality control ensures that these products are safe and meet the requirements of the regulators and government agencies. The main objective of quality control is to identify and ‎quantify active substances and track impurities using analytical techniques, such ‎as high-performance liquid ‎chromatography (HPLC). However, many of these techniques are time consuming, destructive to samples, damaging to the environment, and expensive to operate and maintain. This study aims to use alternative methods for quality control that are easy to operate, affordable, eco-friendly, and non-destructive to samples. This study examined near infrared spectroscopy (NIRS) and time-domain nuclear magnetic resonance (TD-NMR) in order to produce non-destructive methods for three different quality control issues. The first part of this study focused on measuring the mixture ratios of two different insulin drugs and succeeded by integrating two different TD-NMR techniques. The second part measured the degradation of aspirin to salicylic acid using NIRS and TD-NMR. The third part involved the use of bovine serum albumin as a model drug for biopharmaceuticals. Later, glycation was applied and measured using different TD-NMR techniques to be compared with browning measurements and the O-phthalaldehyde (OPA) method, which are two parameters used to measure glycation. This dissertation has demonstrated that TD-NMR and NIRS are valuable and useful methods for various pharmaceutical quality control procedures as more affordable, eco-friendly, and user-friendly alternatives to the current destructive chemical and chromatographic techniques.

Subject Keywords

Aspirin, Insulin mixtures, Glycation, Time-Domain Nuclear Magnetic Resonance (TD-NMR), Near Infrared Spectrometry ‎‎(NIRS), Pharmaceutical Quality Control ‎

URI

https://hdl.handle.net/11511/109215

Collections

Graduate School of Natural and Applied Sciences, Thesis