RP-HPLC-PDA Method Development, Validation and Stability Studies of the Novel Antineoplastic Drug...

The aim of this study was to establish and validate a reverse phase high-performance liquid chromatography (RP-HPLC) method for determining DEC and Cedazuridine simultaneously (CED). Methodology: The developed method was then used to observe analytes' degradation under the influence of various forced degradation conditions. Analytes were resolved on a C18, 250 x 4.6 mm, particle size 5 m Xterra column with a mobile phase of 0.1 percent Ortho Phospharic Acid buffer pH 6.5: Methanol (40:60v/v) at 1 mL/min and a 10 mL injection capacity. Quantification was done with a PDA detector set to an isosbestic point of 220 nm and a linear calibration curve for DEC and CED in the concentration ranges of 35-175 g/mL and 100-500 g/mL, respectively. Results: The established method was validated according to ICH guidelines, which included linearity, accuracy, precision, and robustness. For CED, the limits of detection (LOD) and quantification (LOQ) were found to be 2.69 g/mL and 8.15 g/mL, respectively. DEC has a LOD and LOQ of 1.55 g/mL and 4.68 g/mL, respectively. Furthermore, a validated method was used to investigate the analyte degradation profile under different stress degradation conditions. Conclusion: The proposed method was found to be sensitive and specific, and it was successfully used to estimate decitabine (DEC) and cedazuridine (CED) in bulk and tablets.

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