A Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (Lc-Ms/Ms) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and Its Application to a Bioequivalence Study

Table 7

Confirmatory incurred sample reanalysis of R(+)-ketorolac and S(−)-ketorolac.

	R(+)-Ketorolac	S(−)-Ketorolac
No. of total samples taken for ISR	90	90
No. of samples meeting the acceptance criteria (i.e., % difference between original and reanalyzed value must be within 20%)	82	76
% of samples meeting the acceptance criteria	91.1%	84.4%