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 3

Result of validation parameters.

Validation parameter	R(+)-Ketorolac	S(−)-Ketorolac
Internal standard	S(+)-Etodolac	S(+)-Etodolac
Bench top stability (in plasma samples)	9.02 hr at room temperature	9.02 hr at room temperature
Autosampler stability	110.67 hr at 10^∘C in propylene container.	110.67 hr at 10^∘C in propylene container.
Stock solution stability of the drug stored at refrigerated temperature between 1–10∘C	11 days	11 days
Carry over effect in matrix	0% at RT of analyte and IS	0% at RT of analyte and IS
Stock stress stability in aqueous dilutions	8.95 hr at room temperature under low light condition in poly propylene container.	8.95 hr at room temperature under low light condition in poly propylene container.
Recovery	82.04%	70.94%
Freeze thaw stability	3 cycle	3 cycle
Dilution integrity	Dilution at 2 times and 4 times	Dilution at 2 times and 4 times
Limit of quantitation (ng/ml)	9.36	6.07
Analytical range (ng/ml)	9.36–1198.69	6.07–776.74
Long-term stability-1	117 days at temperature below −50^∘C	117 days at temperature below −50^∘C
Long-term stability-2	283 days at temperature below −50^∘C	283 days at temperature below −50^∘C