A Newly Developed Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Dexmethylphenidate and Serdexmethylphenidate with PDA

Aims: The present application is a Newly Validated Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Dexmethylphenidate and Serdexmethylphenidate with PDA.

Study design: Mentioned study is a quick, rapid, economical, precise, and accurate reverse phase- high performance liquid chromatographic method for estimating Dexmethylphenidate and Serdexmethylphenidate.

Place and duration of study: The present assay was carried out at the Shree icon Pharma laboratories PVT.ltd, Vijayawada, AP, and India, from December 2020 to February 2021.

Methodology: The stationary phase Agilent C18 column with dimensions of 150x4.6mm, 3.5 was used for chromatography and pH-2.5 ammonium acetate buffer with orthophosphoric acid: acetonitrile in a 50:50 ratio used as a buffer. The detection wavelength was 265nm, and the flow rate was 1mL/min. The strategy was justified according to ICH guidelines

Results: Dexmethylphenidate and Serdexmethylphenidate had retention periods of 4.258 and 5.629 minutes, respectively. For the estimation of Dexmethylphenidate and Serdexmethylphenidate, the method has been validated for linearity, accuracy, precision, stability tests, and forced degradation studies including acid, base, hydrolysis, peroxide, and thermal degradation. By multiplying the quality six times, the system's suitability parameter was investigated, and they were well within reasonable limits. The regression coefficient of the two drugs was found to be 0.999 during the linearity study, which was performed at 10% to 150 percentage points. Precision results for Dexmethylphenidate and Serdexmethylphenidate were 0.54 and 1.24, respectively. The drugs were recovered at a rate of 98-102 percent, which is within the acceptable range.

Conclusion: The validation results were found to be satisfactory. It was clear that the proposed method was suitable for routine quality control and analysis of pharmaceutical preparations.