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)