Published April 14, 2023 | Version v1

VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION CONTENT AND IMPURITIES OF NURTEC ODT(RIMEGEPANT SULFATE ORALLY DISINTEGRATING TABLETS) IN BULK AND PHARMACEUTICAL DOSAGE FORM

  • 1. Analytical Research & Development, Changzhou Pharmaceutical Factory, Changzhou - 213018, China.
  • 2. Formulation Research & Development, Changzhou Pharmaceutical Factory, Changzhou - 213018, China.

Description

A simple, accurate, precise, and rapid stability indicating reverse phase A performance liquid chromatography method was used for the estimation of rimegepant sulfate orally disintegrating tablets in bulk and oral dosage form. The proposed analytical method has been validated for content and impurities of specificity, linearity, accuracy, precision, and robustness. The chromatography was achieved in an Agilent Eclipse XDB-C18 (length 150 x diameter 4.6 mm, particle size 5µm) column with gradient flow. The optimal chromatographic condition consisted of mobile phase with a flow rate of 1.0 mL/min, a column temperature of 30 °C, a run time of 25 minutes, and a detector wavelength of 265 nm.

 

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