Research Article
Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis
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 supplier | flow rate (mL min−1) | | | 3.6 | 4.0 | 28 | 32 | Shim-pack C18 | ODS-Hypersil | 0.8 | 1.2 |
| Amount (%) | 99.67 | 100.24 | 100.18 | 99.93 | 99.51 | 99.67 | 100.38 | 99.99 | 98.67 | RSD (%) | 1.23 | 0.33 | 0.53 | 1.31 | 0.73 | 1.23 | 1.21 | 1.34 | 1.40 | Retention time | 4.83 | 4.67 | 4.79 | 5.63 | 4.18 | 4.83 | 5.89 | 8.96 | 4.03 | Theoretical plates | 12767.9 | 12355.3 | 13047.4 | 13366.2 | 11544.6 | 12767.9 | 6316 | 14810.2 | 10581.1 |
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anominal condition: pH 3.8; flow rate 1.0 mL min−1; concentration of organic solvent 30.0%; column Shim-pack C18.
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