A validated stability indicating Rp-Hplc method development and validation for simultaneous estimation of serdexmethylphenidate and dexmethylphenidate in pharmaceutical dosage form
A simple, Accurate, precise method was developed for the simultaneous estimation of the Serdexmethylphenidate and Dexmethylphenidate in Tablet dosage form. Chromatogram was run through Std Ascentis C18 (150 x 4.6 mm, 2.4m) Mobile phase containing Buffer 0.01N NAH2PO4: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 0.9 ml/min. Buffer used in this method was 0.01N NAH2PO4 buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 228 nm. Retention time of Serdexmethylphenidate and Dexmethylphenidate were found to be 2.133 min and 2.925 min. %RSD of the Serdexmethylphenidate and Dexmethylphenidate were and found to be 0.6 and 0.4 respectively. %Recovery was obtained as 99.98% and 100.50% for Serdexmethylphenidate and Dexmethylphenidate respectively. LOD, LOQ values obtained from regression equations of Serdexmethylphenidate and Dexmethylphenidate were 0.24, 0.73 µg/ml and 0.04, 0.12µg/ml respectively. Regression equation of Serdexmethylphenidate is y = 71326x + 10084, and y = 85514x + 10852.of Dexmethylphenidate. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
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