Development and validation of an optimized RP - HPLC method for the concurrent analysis of decitabine and cedazuridine

Decitabine and cedazuridine were analysed simultaneously using a reverse - phase RP - HPLC technique that was refined and verified. A Kromosil C18 column (250 mm × 4.6 mm, 5 μm) was used to produce chromatographic separation under isocratic elution conditions. Phosphate buffer (pH 4.5) and methanol (20:80 v/v) made up the mobile phase. The buffer was made from potassium dihydrogen orthophosphate, and the pH was modified with orthophosphoric acid. A photodiode array (PDA) detector set at 254 nm was used for dete ction, and the flow rate was set at 1.0 mL/min. With a 20 μL injection volume and a 10 - minute run period, the column was kept at room temperature.It was discovered that the linearity of cedazuridine and decitabine ranged from 1 to 5 μg/mL and 100 to 500 μg /mL, respectively.The coefficient of linear regression did not exceed 0.999.Decitabine as well as cedazuridine had respective precisions of 0.2% and 0.6%.Decitabine %RSD 0.2 and cedazuridine %RSD 0.1 have intermediate precision. In order to determine the % recovery for Decitabine (99.84%) and Cedazuridine (100.51%), the accuracy was assessed.LOD and LOQ were determined to be within the range.The findings on the validation parameters satisfied USP and ICH standards.It concluded that the procedure was straigh tforward, linear, accurate, and precise. It was discovered that the technique may be applied with a high degree of accuracy and precision in ordinary laboratory analysis .