Table 5: Results from robustness testing of the LC method for paliperidone in extended-release OROS tablets.

Robustness condition
Nominal conditiona pH of aqueous solvent Concentration of organic solvent (%)Column supplierflow rate (mL min−1)
3.64.02832Shim-pack C18ODS-Hypersil0.81.2

Amount (%)99.67100.24100.1899.9399.5199.67100.3899.9998.67
RSD (%)1.230.330.531.310.731.231.211.341.40
Retention time4.834.674.795.634.184.835.898.964.03
Theoretical plates12767.912355.313047.413366.211544.612767.9631614810.210581.1

anominal condition: pH 3.8; flow rate 1.0 mL min−1; concentration of organic solvent 30.0%; column Shim-pack C18.