A Novel Stability Indicating RP-HPLC Method for Simultaneous Quantification of Serdexmethylphenidate and Dexmethylphenidate in Fixed Dosage Form

Abstract

A simple, robust stability indicating RP-HPLC method was developed for simultaneous quantification of serdexmethyl phenidate and dexmethyl phenidate in a fixed capsule dosage form. This is the first method to be reported for simultaneous estimation and quantification of degradation products produced from forced stressing of the dosage form as per ICH guidelines. The chromatographic separation was attained on Waters X-terra C18 column using a mixture of trifluoro acetic acid and acetonitrile (70:30 v/v) as mobile phase with a flow rate of 1 mL, monitored at 265 nm over a run time of 10 min. Serdexmethyl phenidate and dexmethyl phenidate were eluted with retention times of 2.71 min and 7.33 min, respectively. The method displayed linear responses in the range of 4.2–63 μg/mL (0.9994) for serdexmethyl phenidate and 0.9 to 3.5 μg/mL (0.9998) for dexmethyl phenidate, respectively. The percentage recoveries of the two drugs were found within the acceptable limits. Forced degradation was conducted and showed considerable degradation in various stress conditions. It also confirms the specificity of the method as no interference peaks were observed concerning for to stress products. This method can be routinely used in quality control labs for simultaneous determination of respective drugs in marketed dosage form.

Chromatographic reversed HPLC and TLC-densitometry methods for simultaneous determination of serdexmethylphenidate and dexmethylphenidate in presence of their degradation products—with computational assessment

“…In these studies, partial degradation of the drug was accomplished using various forced degradation conditions. In one study [ 5 ], forced degradation was carried out by exposing dosage form to various stress conditions including HCl (0.1 N and 1 N) and NaOH (0.1 N and 1 N) at room temperature for 24 h to know the percentage degradation. Both drugs showed very little degradation (3.1–3.3%) in mild and (21.5–24.9%) in harsher acidic and basic stress.…”

“…A number of HPLC assay methods [5][6][7] were reported for determination of SER.DMP and DMP in pharmaceutical formulation and bulk powder. In these studies, partial degradation of the drug was accomplished using various forced degradation conditions.…”

“…1C. A literature review revealed that both drugs were simultaneously determined using HPLC methods [5][6][7]. None of the reported methods identified the degradation products.…”

“…The chemical name of DMP is (R,R)-( +)-Methyl 2-phenyl-2-(2-piperidyl)acetate [ 1 , 2 ], {the d-( +) throe-enantiomer of methylphenidate} [ 1 , 2 ] and its structural formula is shown in Fig. 1 C. A literature review revealed that both drugs were simultaneously determined using HPLC methods [ 5 – 7 ]. None of the reported methods identified the degradation products.…”

“…5) and newly developed methods with respect to Chromatographic Conditions, acid and alkaline degradation, method validation and verification of practical outcomes by Molecular Dynamic Simulation Technique (MDST) is provided in Table7. The published method (Ref 5…”