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

Table 1

RP-HPLC analytical method risk assessment for atorvastatin.

Critical attributes response	Various RP-HPLC chromatographic conditions for atorvastatin
	Composition of mobile phase	UV wavelength	Injection volume	Column temperature	Flow rate	Sample temperature	Column dimension	Type of vial
Chromatogram area	+2	+1	−1	−1	+2	−1	+1	−1
Retention time	+2	+1	−1	+1	+2	−1	+1	−1
Tailing factor	+2	+1	−1	−1	+1	−1	+1	−1

+2, high-risk parameter; +1, medium-risk parameter; −1, low-risk parameter.