Method Development and Validation of RP-HPLC Method for Assay of Extended-release Pharmaceutical Solid Dosage Form for the Treatment of CNS-acting Drug Product

Introduction:Dexmethylphenidate is a CNS stimulant agent and from the literature search, the available methods were Spectrophotometric and HPTLC. Objectives:The objectives of this work were to develop an accurate, simple, time-efficient, as well as precise (Fast or rapid) reversephase analytical HPLC method. Materials and Methods:On a SHISHA-DO, C18, 250 x 4.6mm, 5 size column, the separation of this drug was obtained with a mobile phase made up of 0.5 percent orthophosphoric acid, acetonitrile, and methanol (20:10:70v/v) at a flow rate of 1ml/m, with UV detection at 226nm. Results:Retention time was measured at 1.2, and linearity between 50 and 150g/ml was discovered.For recovery, linearity, LOD, LOQ, precision, and accuracy, this technique has been statistically verified. Conclusion:The findings showed that the linearity, precision, accuracy, LOD, and LOQ of the technique were satisfactorily verified.