International guidelines for HPLC/ UPLC calibration

[praveenpaliwal]

Hi,

Can any body tell me about any international guideline or FDA guideline for HPLC and UPLC?? searched them on internet but could not get sufficient information? CAn any body send me these guide lines??

Best regards

Praveen

[JGK]

Praveen,

In this area the use of terminology is interchangeable and confusing.

Calibration implies testing (and adjustment if required) and would usually be performed according to the manufacturer's trained service providers working to specifications set out by the manufacturer (there may differ between manufacturers.

However, you could be referring to "qualification" (annual performance testing or daily system suitability testing) performed by the end user to ensure that the instrument performs to the same standard consitently.

Given the massive amount of differing applications HPLC and now UPLC is used for as well as the huge range of manufactruers, there is not a single unifying set of criteria.