A large pharmaceutical company is developing a new paracetamol (Fig. 1) tablet formulation. Magnesium stearate (Fig. 2) will be added to the formulation as a powder lubricant for the tableting process. a. Suggest two techniques, one that can be used to assay paracetamol and one that can be used to assay magnesium. Justify your answer. b. Discuss the important practical considerations (e.g., sample preparation and instrument measurement) when using these techniques for this particular sample. Fig. 1.Structure of paracetamol. Fig. 2. Structure of magnesium stearate 2.Chromatography Describe using relevant examples the plate theory as applied to chromatographic separations and explain why it has been superseded by the rate theory. 3.Analytical Process Giving examples, explain what inter-laboratory comparisons are and how they help maintain and enhance the quality of analysis. 4.Mass Spectrometry i. Describe briefly how electrospray ionisation (ESI) works, what types of ions are formed and why it is commonly used when mass spectrometers are coupled with HPLC instruments. ii. Explain how proton/deuterium exchange mass spectrometry works using an example molecule of your choice and explain the benefits and limitations when used for structure elucidation. 5. Design of Experiments Give a brief overview of the main features of Design of Experiments (DOE) and its importance in the pharmaceutical industry. Your answers should included examples of techniques that are used in DOE, how they differ from one another and the benefits and limitations of the different techniques.
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