Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.
In the present study, a simulation was performed for the ICH Q2B guideline for assessing the accuracy. By means of an experimental data set a permutation has been performed to investigate in which interval experimental mean recovery can be expected to scatter just by random effects. A good agreement has been found between the experimental intervals obtained by means of a permutation and the statistically derived confidence intervals. These findings could be confirmed with additionally generated virtual data sets with a true mean of 100% and a true standard deviation of 0.7%.
Schepers
U
U
Institute of Pharmaceutical Chemistry, TU Braunschweig, Beethovenstr. 55, 38106 Braunschweig, Germany.
El Deeb
S
S
Ermer
J
J
Wätzig
H
H
D002623:Chemistry Techniques, Analytical / Q000379:methods / Q000592:standards*; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D003198:Computer Simulation; D005905:Glyburide / Q000032:analysis; D017408:Guidelines as Topic; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
D004364:Pharmaceutical Preparations; D005905:Glyburide