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Stability indicating RP-UPLC method for the determination of Lacosamide and its impurities in Bulk drugs and its pharmaceutical dosage forms | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
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Abstract

Stability indicating RP-UPLC method for the determination of Lacosamide and its impurities in Bulk drugs and its pharmaceutical dosage forms

Author(s): Srihari Molleti, Vinay Rao and K. N. Jayaveera

A novel stability-indicating reverse phase Ultra performance liquid chromatography method was developed and validated for the determination of lacosamide (LCM) and its related substances in bulk and pharmaceutical formulations. The separation of impurities from lacosamide was accomplished on HSS C18 Column using (100 x 2.1mm, 1.8μm) 0.01 M mono basic potassium phosphates for adjusting the pH to 2.0 with ortho phosphoric acid: Acetonitrile (85:15, v/v) as mobile phase. The flow rate was 0.7 mL/min and the detection was carried out at 210 nm with run time of 5 minutes. The developed isocratic UPLC method was consequently validated for specificity, linearity, range, accuracy, precision and robustness and shown equivalency with the API Vendor method.


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