Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE IN SYNTHETIC MIXTURE BY USING RP-HPLC

Akshay Namdevrao Londhe* and T. M. Kalyankar

ABSTRACT

A simple, precise, accurate and robust reverse phase RP-HPLC method has developed and validated for the simultaneous estimation of Serdexmethylphenidate and Dexmethylphenidate in API and pharmaceutical dosage form. This method involves a simple isocratic mobile phase Acetonitrile: 0.01N Potassium dihydrogen phosphate (65:35), chromatographic separation using Agilent C18 150x 4.6mm, 5 column and PDA detection by WATERS 2695 HPLC system. The average retention times of Serdexmethylphenidate and Dexmethylphenidate were found to be 2.253min and 2.850min respectively. The assay of Serdexmethylphenidate and Dexmethylphenidate was performed with tablets and the % assay was found to be 100.64% and 100.88% which shows that the method is useful for routine analysis. The linearity of Serdexmethylphenidate and Dexmethylphenidate was found to be linear with a R2 of 0.999 for all the drugs this shows that the method is able of produce good sensitivity. The acceptance criteria of precision is %RSD should be not more than 2.0% and the method show precision 0.8 and 1.0 for Serdexmethylphenidate and Dexmethylphenidate which shows that the method is precise.

Keywords: Serdexmethylphenidate. Dexmethylphenidate, Method development, Rp-Hplc.