Premium
Determination of rupatadine in pharmaceutical formulations by a validated stability‐indicating MEKC method
Author(s) -
Nogueira Daniele Rubert,
da Silva Sangoi Maximiliano,
da Silva Lucélia Magalhães,
Todeschini Vítor,
Dalmora Sérgio Luiz
Publication year - 2008
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200800254
Subject(s) - chromatography , chemistry , nimesulide , capillary electrophoresis , dosage form , analytical chemistry (journal) , capillary action , quantitative analysis (chemistry) , pharmaceutical formulation , detection limit , materials science , biochemistry , composite material
A stability‐indicating MEKC was developed and validated for the analysis of rupatadine in tablet dosage forms, using nimesulide as internal standard. The MEKC method was performed on a fused‐silica capillary (50 μm id; effective length, 40 cm). The BGE consisted of 15 mM borate buffer and 25 mM anionic detergent SDS solution at pH 10. The capillary temperature was maintained at 35°C and the applied voltage was 25 kV. The injection was performed using the hydrodynamic mode at 50 mbar for 5 s, with detection by photodiode array detector set at 205 nm. The method was linear in the range of 0.5–150 μg/mL ( r 2 = 0.9996). The specificity and stability‐indicating capability of the method were proven through degradation studies inclusive by MS, and showing also that there was no interference of the excipients and no increase of the cytotoxicity. The accuracy was 99.98% with bias lower than 1.06%. The LOD and LOQ were 0.1 and 0.5 μg/mL, respectively. The proposed method was successfully applied for the quantitative analysis of rupatadine in pharmaceutical formulations, and the results were compared to a validated RP‐LC method, showing non‐significant difference ( p >0.05).