Abstract
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% orthophosphoric 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, which 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.
Highlights
Dexmethylphenidate, sold under the brand name Focalin among others, is a medication [1, 2] used to treat attention deficit hyperactivity disorder (ADHD) [3, 4] in those over the age of five years
Acetonitrile (HPLC-grade), orthophosphoric acid, water were purchased from Merck India Ltd, Mumbai, India
Dexmethylphenidate and Serdexmethylphenidate standard was procured from Glenmark, Mumbai
Summary
Dexmethylphenidate, sold under the brand name Focalin among others, is a medication [1, 2] used to treat attention deficit hyperactivity disorder (ADHD) [3, 4] in those over the age of five years. If no benefit is seen after four weeks, it is reasonable to discontinue its use. Common side effects include abdominal pain [6, 7], loss of appetite [8], and fever [9, 10]. Serious side effects may include abuse [11], psychosis [12], sudden cardiac death [13, 14], mania [15], anaphylaxis [16], seizures [17], and dangerously prolonged erection. Dexmethylphenidate is a central nervous system (CNS) stimulant [18]. It is the more active enantiomer of methylphenidate
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