Has anyone experience in standards or standard mixtures for HPLC with UV detection for performing performance qualification tests?
I am searching for e.g. a mixture of 2-3 compounds that is suitable for that. Stability of the substances is also important to store them and repeat the test later...
Thank you.
What are your goals for this benchmarking? Verification of quantitation and retention for an analytical method? I would try to use positive and negative controls for this purpose. It would also validate peak shape for the compounds of interest.
This link gives a little information:
https://www.waters.com/webassets/cms/library/docs/720001983en.pdf
See the section "benchmarking system performance"
To test what? A column, a specific detector? Which test and for what exact purpose or goals ? This should all be defined in detail as part of a SOP. We usually have about 40 to 50 different SOP's just dedicated to routine OQ tests for a specific instrument. Different modules may add many more to the list.
For HPLC column only tests, I have three recommendations. (1) Develop and use your own scientifically established test. Make it specific, to a specific column type and insure that it includes a "special" standard, if it is used to validate a specific column for a specific application (something similar to the sample being run). A detailed SOP should describe the test. (2) If possible, make the test easy to perform, using a simple mobile phase, well established running conditions suitable for use on a variety of HPLC systems. (3) Review the article link for examples and ideas.
"HPLC COLUMN TEST MIXTURE SOLUTIONS; NP & RP EXAMPLES"; https://hplctips.blogspot.com/2017/07/hplc-column-test-mixture-solutions-np.html
Thank you for your suggestions.
In general the column performance and detector performance should be tested. As well as precision and linearity.
So I just wanted to know which compounds/compound mixtures are suitable and available. Also regarding storage of the standards for reevaluation after weeks or defined number of injections....
It is best to get some formal training to better understand what you are asking about (or have your company hire a trained chromatographer). Please read my previous response for the answers (and questions). Select a suitable standard or standard mixture for the specific test, as appropriate to the test. You will need different compounds for different tests. Depending on which modules (or columns) you wish to test, there will be a LOT of SOPs written for just one instrument configuration. A lot. Have you ever looked at an instrument manufacturer's IQ and OQ test SOPs as examples? That will give you an idea of what is used just for the hardware and software, not the columns or methods!
Columns should have two different kinds of tests run. One, at the time of receipt to establish a baseline condition and for comparison to additional columns you will purchase over time (an incoming QC test. Never rely on the column vendors' own QC test sheet as it is not designed to meet your goals). No two columns are the same and some of course have nothing in common at all. Document, test, and record the data obtained by serial number and type for each one. The previous link I shared has good examples of column test mixtures (mix your own or buy them as "kits" from the chemical suppliers). Also, columns are consumable items so you will dispose of them and replace them with another column. The tests used should be run periodically to monitor the column's performance over time. Always have extra, new, tested columns on hand.
The second "Column Test" you need to run relates to each method. Every method requires a test to show the method makes scientific sense and is reproducible. A test mix which relates to the samples being run on it for THAT method should be used as a "check" and verification. This is extremely useful as it gives you something to go back and check.
Instrument hardware requires different types of tests. When "chk" standards are needed, first determine if the instrument has one built-in (i.e. holmium oxide for UV/VIS detectors). This will save time and money.
As to storage, this depends on which std you choose and what form or packaging they come in. Refer to the chemical suppliers (and a chemist's) detailed information regarding what you purchase for recommended initial storage suggestions. Best advice is buy fresh, store as required (rt, cold, in the dark ... ), perform degradation studies to validate it and be careful if you make your own dilutions to be sure you have a way to double check the concentration has not changed.
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