Help With HPLC Sample QC and System Suitability

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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I’m relatively new to liquid chromatography, and I’ve recently been tasked with updating/revising our current UPLC vitamin assays for a nutraceutical company. I’ve been having trouble finding clear information on some topics. My primary concern at this juncture is determining which sample quality checks to use; I’m more familiar with ICP-MS and EPA method 6020b, where it is spelled out very clearly (MS/MSD, LCS, CCV etc.) I’m also aware of typical system suitability checks for HPLC (Tailing, k’, resolution etc.) Additionally, many of the articles I’ve found are about impurities/limit tests, not assays, and I am unsure if the quality checks are the same for both.

I’m planning on redoing all of the validation protocols for our methods, and I understand that some QC samples/system suitability checks are going to be reliant on the validation data. I just need somewhere to start. There is no one above me I can ask, and my resources are limited.

For simplicity’s sake, I’d start with our cholecalciferol UPLC-MS/MS method; our instrument is an Acquity H-Class Xevo TQD. Our current quality checks consist of ICV recovery after the calibration standards, duplicate calibration midpoint recovery(at the end of the run) and retention time comparison. The only system suitability we currently monitor is the pressure..

Any insight would be immensely appreciated.

If you're working with a finished dosage form or material for use in one, is it a USP item?
If so, consult the USP for requirements.
2 posts Page 1 of 1

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