Help on: Troubleshooting in pharmaceutical analysis

MTS HELPDESK

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Question:
"What are the general problems occurring in HPLC, GC and spectroscopy during operation in the pharmaceutical industry?”

Answer:
“A full discussion of the general problems which can occur when operating HPLC, GC and spectroscopy for applications in the pharmaceutical industry could run to several books! In my experience the greatest problems are usually due to a lack of experience, knowledge and skills on the part of the operator (that’s probably the answer you would expect from a trainer!).

Modern analytical instruments have developed to such an extent that they can be fairly simple to use, with sophisticated software that lulls you into a false sense of security about your own abilities. It pays to remember what is actually happening during analysis and a good background in the theory of the technique will enable effective troubleshooting.

If you consider HPLC, setting up a run and then processing it can be quite a straightforward task. But, if the results are not as expected then a solid understanding of the method will help to assess the available information and diagnose the problem. This knowledge extends to an understanding of how the instrumentation works, an example being the selection and use of a suitable wash solvent to prevent carryover of your analyte from one injection to another. Most often, problems will occur when developing methods for new compounds, since that is when knowledge and skills are tested most.

The answer to building suitable skills and knowledge is primarily through effective training (which Mourne Training Services is always happy to provide) but developing experience after the training is equally important. Making sure that learning is fully implemented and kept up to date is a significant challenge for both individuals and managers in the pharma industry. Troubleshooting problems actually helps to develop expertise.

There is a wealth of information to be found on the web relating to troubleshooting of all these techniques. For example, type ‘HPLC troubleshooting’ into a search engine and you will be presented with numerous helpful resources. I recommend chromatography magazines such as LCGC which has regular troubleshooting columns for both LC and GC. There are also many books available which provide more in-depth knowledge regarding troubleshooting.”