Chromatography Research International

Research Article

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 5

Freeze thaw stability, bench top stability, autosampler stability, and long-term stability data of R(+)-ket orolac and S(−)-ketorolac in human Plasma.


Storage period and condition	Analyte		Nominal		CV(%)	%Accuracy	%Stability
Storage period and condition	Analyte	Sample type	Conc.(ng/mL)	Mean	CV(%)	%Accuracy	%Stability

Freeze thaw cycles(3 cycles)	R(+)-ketorolac	LQC	24.57	24.46	3.2	99.5	101.1
	R(+)-ketorolac	HQC	984.42	1015.94	3.2	103.2	102.5
	S(−)-ketorolac	LQC	15.95	15.2	3.9	95.3	99.6
	S(−)-ketorolac	HQC	639.14	625.65	4.4	97.9	101.6

Bench top stability in plasma samples (9.02 hours)	R(+)-ketorolac	LQC	24.57	26.57	3.6	108.2	104.5
	R(+)-ketorolac	HQC	984.42	959.49	2.5	97.5	101
	S(−)-ketorolac	LQC	15.95	15.77	4.2	98.8	103.7
	S(−)-ketorolac	HQC	639.14	587.9	2.4	92	102.8

Autosampler stability (110.67 hours)	R(+)-ketorolac	LQC	24.57	23.15	3.7	94.2	97.5
	R(+)-ketorolac	HQC	984.42	949.18	1.2	96.4	99
	S(−)-ketorolac	LQC	15.95	14.19	3.9	88.9	97
	S(−)-ketorolac	HQC	639.14	571.73	1.8	89.5	97.2

Long term stability 1 (117 Days)	R(+)-ketorolac	LQC	24.57	26.84	2.9	109.2	113
	R(+)-ketorolac	HQC	984.42	1034.84	1.2	105.1	99.5
	S(−)-ketorolac	LQC	15.95	17.39	3.7	109	109.9
	S(−)-ketorolac	HQC	639.14	665.13	1.1	104.1	99.1

Long term stability 2 (283 Days)	R(+)-ketorolac	LQC	24.57	25.72	1.2	104.7	101.3
	R(+)-ketorolac	HQC	984.42	977.32	2.4	99.3	99
	S(−)-ketorolac	LQC	15.95	17.39	1.1	104.5	101.2
	S(−)-ketorolac	HQC	639.14	665.13	2.8	98.6	100