USP Method Transfer of Donepezil Tablets from HPLC to UPLC
The USP compendial method for donepezil tablets was successfully transferred from HPLC to UPLC using the Waters Column Selectivity Chart and ACQUITY UPLC Columns Calculator. Routine use, typical of a QC laboratory analyzing a formulated donepezil tablet sample, was evaluated on the ACQUITY UPLC BEH C18 1.7 μm column. Approximately 850 injections were achieved before peak splitting was evident and the method failed system suitability. Troubleshooting steps attributed the cause of failure to sample build-up on the column bed. Due to practical limitations in changes to the sample preparation, the method was transferred to an XBridge C18 XP 2.5 μm column, where approximately 1600 injections were achieved. The method using the XP 2.5 μm column is approximately 80% faster than the HPLC method and results in a 92% savings in sample injected and solvent consumption. In cases where formulated sample is not directly compatible with the original compendial method, the use of XP 2.5 μm columns can provide method ruggedness while still providing significant sample throughput and solvent cost savings.
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