By Anonymous on Wednesday, June 5, 2002 - 07:31 am:
When performing robustness studies how much do you vary temperature, percent organic, pH, etc. and why?
By B.Buglio on Friday, June 7, 2002 - 08:36 am:
Robustness is a measure of the effect, on the
system, of small (but significant) variations in
method parameters. In general the parameters and
values tested should be among those listed below:
pH of mobile phase (+/- 1 unit)
Buffer conc. (+/- 10%)
Ratio of solvents in Mobile Phase (+/- 30 %
relative or +/- 2 % absolute whichever is larger)
Column length (+/- 70 %)
Column diameter (+/ - 25 %)
Flow rate (+/- 50 %)
Particle size of stationary phase (up to 50%)
Injection volumes (up to 2 fold or reduced)
Column temperature (+/- 10%)
These values, some variation of which are commonly
evaluated during a validation, come specifically
from an article by Furman et al (Pharm. Tech. June
1998) which discussed the issue of adjustment vs.
modification.
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