Investigation on the photochemical stability of lercanidipine and its determination in tablets by HPLC-UV and LC-ESI-MS/MS

J Pharm Biomed Anal. 2006 Apr 11;41(1):176-81. doi: 10.1016/j.jpba.2005.11.018. Epub 2005 Dec 27.

Abstract

The photostability of lercanidipine, a dihydropyridine calcium-channel blocker used in the treatment of the hypertension, was studied. Drug substance and its solutions and formulations were exposed to UV-A radiations (solar simulator) and the photodegradation process was monitored by UV spectrophotometry, HPLC and HPLC-mass spectrometry. The effect of the solvent (ethanol and ethanol/PBS 1:1 v/v) on the photodegradation pathway and kinetic was evaluated. Lercanidipine and its photodegradation products were separated by a selective reversed-phase HPLC method and the main photoproducts were characterized by HPLC-MS/MS analysis, using an electrospray ionization source (ESI) and an ion trap analyzer. Photochemical reactions, involved in the photodegradation of lercanidipine, include aromatisation of the dihydropyridine moiety, formation of nitrosoderivatives and N-dealkylation in the side chain. The developed stability-indicating HPLC method was then applied to the quality control of commercially available lercanidipine formulations (tablets).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Calcium Channel Blockers / analysis
  • Calcium Channel Blockers / chemistry*
  • Calibration
  • Chemistry, Pharmaceutical / methods*
  • Chromatography, High Pressure Liquid / methods*
  • Chromatography, Liquid / methods*
  • Dihydropyridines / analysis
  • Dihydropyridines / chemistry*
  • Ethanol / chemistry
  • Kinetics
  • Light
  • Mass Spectrometry / methods*
  • Models, Chemical
  • Photochemistry / methods*
  • Solvents
  • Spectrometry, Mass, Electrospray Ionization / methods*
  • Spectrophotometry, Ultraviolet / methods*
  • Tablets / analysis

Substances

  • Calcium Channel Blockers
  • Dihydropyridines
  • Solvents
  • Tablets
  • Ethanol
  • lercanidipine