Transfer of drug dissolution testing by statistical approaches: Case study.

The analytical transfer is a complete process that consists in transferring an analytical procedure from a sending laboratory to a receiving laboratory. After having experimentally demonstrated that also masters the procedure in order to avoid problems in the future. Method of transfers is now commonplace during the life cycle of analytical method in the pharmaceutical industry. No official guideline exists for a transfer methodology in pharmaceutical analysis and the regulatory word of transfer is more ambiguous than for validation. Therefore, in this study, Gauge repeatability and reproducibility (R&R) studies associated with other multivariate statistics appropriates were successfully applied for the transfer of the dissolution test of diclofenac sodium as a case study from a sending laboratory A (accredited laboratory) to a receiving laboratory B. The HPLC method for the determination of the percent release of diclofenac sodium in solid pharmaceutical forms (one is the discovered product and another generic) was validated using accuracy profile (total error) in the sender laboratory A. The results showed that the receiver laboratory B masters the test dissolution process, using the same HPLC analytical procedure developed in laboratory A. In conclusion, if the sender used the total error to validate its analytical method, dissolution test can be successfully transferred without mastering the analytical method validation by receiving laboratory B and the pharmaceutical analysis method state should be maintained to ensure the same reliable results in the receiving laboratory.