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: Validation of the developed method was performed as per ICH guidelines viz., linearity, accuracy, precision, and robustness. The limits of detection (LOD) and the limits of quantification (LOQ) for CED were found to be 2.69 µg/mL and 8.15 µg/mL respectively. LOD and LOQ for DEC 1.55 µg/mL and 4.68 µg/mL respectively. Moreover, validated method was applied to study the degradation profile of analytes under various stress degradation conditions.

Conclusion: The proposed method was found to be sensitive, specific and was successfully applied for the simultaneous estimation of Decitabine (DEC) and Cedazuridine (CED) in bulk drug, and tablets.

Please see the link :- https://www.journaljpri.com/index.php/JPRI/article/view/30928