alexa Abstract | A stability indicating method development and validation for determination of Methylphenidate Hydrochloride and its impurities in solid pharmaceutical oral dosage form by RP-HPLC as per ICH guidelines

Journal of Chemical and Pharmaceutical Research
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Abstract

A simple, rapid, and precise, robust and rugged reverse phase high performance liquid chromatographic (RPHPLC) method for analysis of Methylphenidate hydrochloride (MPH) and its Impurities in a tablet dosage form have been developed and validated. This method condition optimization was performed with HSSD waters symmetry C18 (100x 40 i.d., 3.7 μm particle column with Mobile phase Methanol: Acetonitrile: buffer (50:20:30v/v/v) and pH adjusted 4.0 with acetic acid at a flow rate of 1.5 ml/min. The eluted compounds were detected and monitored at 210 nm for Methylphenidate Hydrochloride (MPH) assay and 203 nm for related substances (RS) by PDA detector. By this method Methylphenidate Hydrochloride (MPH), Imp-A, Imp-B were eluted with retention times of 3.162, 2.349, and 2.792 min, respectively. Validation revealed the method is accurate, precise, reliable, and reproducible. Calibration curve plots were linear over the concentration ranges 0.1-2.0 μg/mL for Impurities and for MPH 500- 1500 μg/. Limits of detection (LOD) for MPH, Imp-A, Imp-B were 0.03, 0.04, and 0.04μg/ml and limits of quantification (LOQ) were 0.1, 0.1, 0.1 μg/mL respectively. The statistical analysis proves the method is suitable for the analysis of MPH, Imp-A, Imp-B in bulk and tablet dosage form without any interference from the excipients. It was also proved study for degradation kinetics of the drug in tablet dosage form. The developed method separated MPH from its two known and two unknown impurities within 6.0 min. Methylphenidate Hydrochloride(MPH) was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. MPH was found to degrade significantly in base stress condition, degrade slightly in oxidative stress condition and remain stable in acid, hydrolytic, thermal and photolytic degradation conditions. All impurities were well resolved from each other and from the main peak, showing the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines.

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Author(s): Ch Naveen Kumar and N Kannappan

Keywords

Methylphenidate Hydrochloride (MPH), Impurities, RP-HPLC, Stability Indicating, Method Development, Validation, ICH guidelines., RP-HPLC

 
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