Investigation on the photochemical stability of lercanidipine and its determination in tablets by HPLC-UV and LC-ESI-MS/MS.
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).
Fiori
Jessica
J
Dipartimento di Scienze Farmaceutiche, Alma Mater Studiorum-Università di Bologna, Via Belmeloro 6, 40126 Bologna, Italy.
Gotti
Roberto
R
Bertucci
Carlo
C
Cavrini
Vanni
V
D002121:Calcium Channel Blockers / Q000032:analysis / Q000737:chemistry*; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D004095:Dihydropyridines / Q000032:analysis / Q000737:chemistry*; D000431:Ethanol / Q000737:chemistry; D007700:Kinetics; D008027:Light; D013058:Mass Spectrometry / Q000379:methods*; D008956:Models, Chemical; D010777:Photochemistry / Q000379:methods*; D012997:Solvents; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013607:Tablets / Q000032:analysis
D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D012997:Solvents; D013607:Tablets; D000431:Ethanol; C060343:lercanidipine