Development and validation of rp-hplc method for the simultaneous estimation of serdexmethylphenidate and dexmethylphenidate in bulk and pharmaceutical dosage form

Abstract

An accurate, precise, simple, efficient and reproducible, isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Serdexmethylphenidate and Dexmethylphenidate in bulk and combined pharmaceutical tablet dosage forms. Serdexmethylphenidate and Dexmethylphenidate were separated by using a Symmetry ODS C18 (4.6mm×150mm) 5µm Particle Size; Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Methanol: 0.1% Orthophosphoric acid (64:36% v/v). The flow rate was set to 1ml/min with the responses measured at 224nm. The retention time of Serdexmethylphenidate and Dexmethylphenidate was found to be 2.808min and 3.880min respectively with resolution of 5.68. Linearity was established for Serdexmethylphenidate and Dexmethylphenidate in the range of 20-100µg/ml for Serdexmethylphenidate and 60-140µg/ml for Dexmethylphenidate with correlation coefficient 0.999. The percentage recovery was found to be is 100.30% for Serdexmethylphenidate and 100.21% for Dexmethylphenidate respectively. Validation parameters such as specificity, linearity, precision, accuracy and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantification of bulk and active pharmaceutical ingredient present and in combined tablet dosage form.