The combination of gemcitabine (GEM) and olaparib (OLA) shows promise for treating pancreatic cancer, particularly in patients with mutations in the BRCA genes. This work presents the validation of a straightforward, fast, and sensitive chromatographic method for the simultaneous analysis of GEM and OLA, supporting the development of advanced pharmaceutical formulations that combine the two drugs. The efficient chromatographic separation of GEM and OLA was achieved using a C18 column (250 × 4.6 mm, 5 μm) with a mobile phase composed of acetonitrile and water (50:50, v/v), which eluted isocratically at a flow rate of 0.8 mL/min. Determinations were performed using a PDA detector at 243 nm for both drugs. The retention times for GEM and OLA were approximately 3.3 and 4.3 min, respectively. The method was linear (R2 > 0.999), with a regression curve in the concentration range of 0.5 to 10.0 μg/mL, demonstrating sensitivity, precision, and accuracy. The recovery rates of the drugs from the pancreatic tissue were higher than 97.0%. The components of a coated liposomal formulation and the pancreatic tissue did not interfere with the analysis, and both drugs demonstrated a low degradation rate under stressful conditions. In conclusion, the validated method was suitable for quantifying GEM and OLA simultaneously, even in a biological matrix, making it feasible to support the development of advanced pharmaceutical formulations that incorporate both drugs, such as liposomes.
Silva et al. (Thu,) studied this question.