Determination of rupatadine in pharmaceutical formulations by a validated stability-indicating MEKC method

✍ Scribed by Daniele Rubert Nogueira; Maximiliano da Silva Sangoi; Lucélia Magalhães da Silva; Vítor Todeschini; Sérgio Luiz Dalmora

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 337 KB
• Volume: 31
• Category: Article
• ISSN: 1615-9306
• DOI: 10.1002/jssc.200800254

✦ Synopsis

Abstract

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).