Development and application of a validated stability-indicating ultra-performance liquid chromatography (UPLC) method for the determination of dantrolene and its related impurities

Mobin A. Tawakkul, Patrick J. Faustino, Vilayat A. Sayeed, Mansoor A. Khan, Saeed R. Khan

Research output: Contribution to journalArticlepeer-review

Abstract

A rapid, sensitive, and specific ultra-performance liquid chromatographic (UPLC) method was developed for the simultaneous determination of dantrolene and its potential degradation impurities. Chromatographic separation was achieved on a Waters Acquity UPLC system using a Waters BEH C18 (2.1 × 100 mm, 1.7 μM) analytical column and Waters BEH C18 (2.1 × 5 mm, 1.7 μM) guard column. The compounds were eluted with a linear acetonitrile gradient (25-75%) over 3 min with a buffer composition of sodium acetate for method development, quantitation, and forced degradation studies. The flow rate was maintained at 0.5 mL/min. Column temperature was maintained at 35°C. Injection volume was 4 μL, and analysis was detected by a photodiode array detector at 375 nm. The method was validated according to USP Category I requirements for dantrolene. Forced degradation of dantrolene was conducted under the conditions of hydrolysis, oxidation, photolysis, and stability-indicating UPLC method was developed and validated. Two degradation products (related compound B and C) were formed in 0.1 N NaOH and 0.1 N HCl, respectively. The dantrolene was stable to oxidative decomposition. The degradation behavior under UV light was similar to 0.1 N HCl conditions. The method was used successfully for the quality assessment of dantrolene and its three impurities.

Original languageEnglish (US)
Pages (from-to)21-29
Number of pages9
JournalClinical Research and Regulatory Affairs
Volume27
Issue number1
DOIs
StatePublished - Mar 2010
Externally publishedYes

Keywords

  • Dantrolene
  • Degradation
  • Impurity
  • UPLC
  • USP related compound A, B, C

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Pharmacology (medical)

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