Learning Outcomes
After the succesful end of the course, postgraduates will be able to develop an analytical method for the quantification of two or three substances in pharmaceutical formulations.
In addition, postgraduates are trained in all the “in process “ analytical methods related to the release of a batch from the production unit to consumption.
Course Content (Syllabus)
1. Introduction to analytical concepts: Quality control of analytical methods. Terms used in the control of analytical procedures. Basic calculations in pharmaceutical analysis.
2. Evaluations and statistical processing of detailed results. Pharmacopoeias and their usefulness as appropriate tools for the application of analytical methods. Applications / Examples. Create an internal / external template reference curve
3. Ultraviolet spectrophotometry, in medicinal substances and in medicinal plants.
4. Stability study of active pharmaceutical compounds in different solvents (MeOH, H2O, HCl 0.1N, NaOH 0.1N) and selection of the most suitable for qualitative UV assays.
5. Descriptive statistics, Estimation, Measurement Uncertainty, confidence limits.
6. Raw material control: General principles of atomic emission and absorption spectrometry. Testing of heavy metal impurities in raw materials by atomically emitted plasma emission spectrometry (ICP-AES)
7. “In process” Drug control methods: Dissolution process. Weight uniformity test. Fragmentation time test. Brittleness test. Control of height (thickness) of tablets. Mechanical strength test of tablets.
8. Quantification of an active compound in tablets, with a UV detector. The quantification will be made using external calibration model of one point.
9. Content Uniformity Test
10. Derivative spectra. Development of an analytical “UV derivative ratio“ method for the determination of two or three APIs.
11. General principles of X-rays, X-ray diffraction. Infrared spectrophotometry.
12. FTIR spectra for drug identification. Determination of thermal properties of drugs using Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA).