Application of the Accuracy Profile to Validation of Chromatographic Method for Determination of Etoposide in Polymeric Matrix

作者：Solano Ana G R^*; Silva Gisele R; Pianetti Gerson A

来源：Latin American Journal of Pharmacy, 2013, 32(2): 275-281.

• Accuracy profile
• Etoposide
• Polymeric implant
• Tolerance interval
• Validation

The validation of an analytical method should demonstrate that the method is suitable for its intended purpose. In the current study, the tolerance interval and accuracy profile, a statistical approach that allows defining a region where a predetermined proportion of future measurements obtained with the method will be observed, were applied to the validation of the chromatographic method for determination of etoposide incorporated into a polymeric implant. Hence, it was possible to define the range of etoposide concentrations to which the method may be applied (4.90 to 63.66 mu g/mL), the quantitation limits (4.61 and 71.0 mu g/mL), and the linearity of the analytical method. The accuracy profile showed to be a reliable and useful tool for the validation of chromatographic methods.

• 出版日期2013