A New Liquid Chromatography-Tandem Mass Spectrometry Method for Determination of Bisoprolol in Human Plasma Samples

Table 6

Stability of analyte in biological matrix after 3 freeze-thaw cycles at −25±10°C.

	Analyte:		Bisoprolol
	Biological matrix:		Human plasma
	Storage condition:		−25±10 °C
	QC1 (3 ng/mL)			QC3 (75 ng/mL)
	Comparison samples		Stability Samples	Comparison Samples		Stability Samples
	Measured	% nominal	Measured	Measured	% nominal	Measured
	Conc.		Conc.	Conc.		Conc.
	3.015	101.860	2.934	70.921	95.788	74.754
	2.879	97.276	3.239	77.073	104.097	73.574
	3.257	110.048	3.096	77.932	105.256	77.879
	2.964	100.136	3.180	70.590	95.340	83.159
	2.943	99.439	3.049	75.582	102.083	78.939
	3.152	106.480	3.063	74.865	101.115	86.426
N	6	6	6	6	6	6
Mean	3.035	102.540	3.093	74.494	100.613	79.121
SD (±)	0.142		0.107	3.092		4.921
CV(%)	4.686		3.454	4.151		6.220
% Change		1.920			6.212
	Acceptance criteria
	67% comparison samples must be 100±15% nominal values
	Mean % nominal of comparison samples 100±15%
	CV (%) ≤ 15%
	% Change ± 15%