Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

Table 6

Stability study of ATS at different quality controls.

Quality control sample	Refrigerated condition and time	Experimental concentration	% experimental drug	% RSD
LOC (1.5 μg/ml)	Initial (0 h)	1.5 ± 0.02	100	1.33
	Short-term storage stability (25°C/24 h)	1.5 ± 0.03	100	1.33
	Long-term stability (−80°C, 30 days)	1.49 ± 0.03	99.33	2.01
	Three cycles freeze-thaw stability (three cycles, −20°C to 25 C)	1.48 ± 0.02	98.66	1.35
	Postpreparative stability (10°C, 24 h), initial (0 h)	1.49 ± 0.03	99.33	2.01
HQC (24 μg/ml)	Initial (0 h)	24 ± 0.2	100	0.83
	Short-term stability (25°C, 24 h)	23.99 ± 0.3	99.95	1.25
	Long-term stability (−80°C, 30 days)	23.90 ± 0.3	99.58	1.26
	Three cycles freeze-thaw stability (three cycles, −20°C to 25°C)	23.92 ± 0.3	99.66	1.25
	Postpreparative stability (10°C, 24 h)	23.98 ± 0.3	99.91	1.25