Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 6th October City, Egypt. Pharmaceutical Chemistry Department, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.
HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories.Managers with a responsibility for generating regulatory submissions.This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.The wide variety of equipment, columns, eluent and operational parameters involved makes high performance liquid chromatography (HPLC) method development seem complex.
The process is influenced by the nature of the analytes and generally follows the following steps: Depending on the overall requirements and nature of the sample and analytes, some of these steps will not be necessary during HPLC analysis.
Consideration must be given to the following: Types of chromatography.
Reverse phase is the choice for the majority of samples, but if acidic or basic analytes are present then reverse phase ion suppression (for weak acids or bases) or reverse phase ion pairing (for strong acids or bases) should be used. For low/medium polarity analytes, normal phase HPLC is a potential candidate, particularly if the separation of isomers is required.
UV wavelengths below 200 nm should be avoided because detector noise increases in this region. The excitation is set to the maximum value then the emission is scanned to locate the emission intensity.
Selection of the initial system could, therefore, be based on assessment of the nature of sample and analytes together with literature data, experience, expert system software and empirical approaches.
Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster.