Table 1:
Factors used during robustness testing applied to LC analysis of paliperidone in extended-release OROS tablets.
Condition
Reference
Variation
pH of aqueous solvent
3.8
3.6; 4.0
Concentration of organic solvent (%)
30.0
28.0; 32.0
Flow rate (mL min
−1
)
1.0
0.8; 1.2
Column supplier
Shim-pack C18, 25 cm
ODS-Hypersil, 25 cm