RP-HPLC method development and validation for simultaneous determination of decitabine and cedazuridine in pure and tablet dosage form

Abstract

Introduction: An attempt has been made to develop a validated stability indicating RP-HPLC method for the estimation of decitabine and cedazuridine. Literature survey revealed that many analytical methods have been reported individually or in combination with other drugs. Retention times were decreased and that run time was decreased, so the method developed was simple and economical. Materials and Methods: It includes the general information on RP-HPLC and method development, general information on forced degradation studies and stress conditions like acid, base, peroxide, thermal, photolytic and neutral. Discussion: The article discusses about drug profiles and official status of selected drugs i.e., decitabine and cedazuridine. Results: In this article the previous literature available for drugs is used for developed research work which Include stability indicating RP-HPLC method development and validation for simultaneous estimation of decitabine and cedazuridine in bulk and their pharmaceutical dosage form. Using Waters HPLC 2695 system, quaternary gradient pump equipped with auto sampler injector with 20 μL is injected eluted with the mobile phase containing 65% 0.01 N KH2 PO4: 35% acetonitrile which is pumped at a flow rate of 1 mL/min and detected by PDA detector at 245 nm. The peak of decitabine and cedazuridine was eluted at retention times of 2.263 min and 3.001 min, respectively. Conclusion: In this paper, HPLC method for the selected drugs showed good linearity.