ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DEXMETHYLPHENIDATE AND SERDEXMETHYLPHENIDATE BY USING RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM
Keywords:Dexmethylphenidate, Serdexmethylphenidate, RP-HPLC, Development, Validation
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the simultaneous measurement of active pharmaceutical ingredients of Dexmethylphenidate and Serdexmethylphenidate.
Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the simultaneous determination of Dexmethylphenidate and Serdexmethylphenidate. The chromatographic strategy utilized inertsil ODS column of dimensions 250x4.6 mm, 5 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% ortho phosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 262 nm utilizing the PDA detector were given in the instrumental settings. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.
Results: LOD and LOQ for the active ingredient were established with respect to test concentration. The calibration chart plotted was linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.
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