Forced degradation study on valbenazine and application of validated stability-indicating HPLC method
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Abstract
Valbenazine, is a medication used to treat tardive dyskinesia. It acts as a vesicular monoamine transporter 2 (VMAT2) inhibitor. The drug was subjected to forced degradation studies as per the conditions prescribed in ICH Q1 (R2) guideline. Valbenazine degraded in hydrolytic (acid and alkaline) and oxidative stress conditions. The drug was found to be stable in thermal and photolytic conditions. The novel degradation products were obtained and were well separated using an HPLC C18 stationary phase Inertsil ODS (150 × 4.6 mm, 5 μm) and mobile phase composed of Phosphate buffer (pH 6.8): Acetonitrile (70:30) pumped at 1.0 mL min−1 flow rate. The column temperature was set at 40°C and the detection at 240 nm using DAD detector. All the degradation products were isolated and characterised. A well resolved chromatographic method proposed in this study suggests that the proposed analytical method finds its application as a stability indicating assay method for the drug and can be used in routine analysis. The developed HPLC method will also suffice the suitability for impurity profiling and assay of Valbenazine in bulk drugs and pharmaceutical formulations.
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References
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