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Analytical Quality by Design (AQbD) approach in developing a highly efficient HPLC-FLD method.Risk-based and proactive approach in HPLC-FLD analytical method development and validation.Optimization of HPLC-FLD method for simultaneous assay of curcuminoids and doxorubicin in liposomes.Method operable design region (MODR) in a HPLC-FLD method for simultaneous assay of curcuminoids and doxorubicin in liposomes.Validation of HPLC-FLD method for simultaneous assay of curcuminoids and doxorubicin in liposomes.The present study highlights the advantages of using an Analytical Quality by Design (AQbD) approach to the optimization of a high-performance liquid chromatography method for the simultaneous assay of curcumin (CUR), demetoxycurcumin (DMC), bisdemetoxycurcumin (BDMC) and doxorubicin (DOX) co-encapsulated in long circulating liposomes. Within the QbD paradigm, the present study aimed to establish the method operable design region (MODR) for the optimization of the high-performance liquid chromatography-fluorescence (HPLC-FLD) assay by means of Design of Experiments (DOE) and response surface methodology, in order to achieve a good separation and quantification of all analyzed compounds along to an acceptable analysis time. A deep understanding of the quality target product profile (QTPP) and of the analytical target profile (ATP), followed by a risk assessment for variables that affect the efficiency of the method led to the development of a precise, accurate and cost-effective method. The assay was linear over the range of 2–20μg/ml for all investigated compounds. The intra-and inter-day precision were less than 2%, with accuracies between 97–104% of the true values. The method was successfully applied to the quantification of curcuminoids and DOX from long-circulating liposomes.