Tags

Type your tag names separated by a space and hit enter

Determination of rupatadine in pharmaceutical formulations by a validated stability-indicating MEKC method.
J Sep Sci. 2008 Sep; 31(16-17):3098-105.JS

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 microm 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 degrees 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 microg/mL (r2=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 microg/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).

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Nogueira DR
Department of Industrial Pharmacy, Federal University of Santa Maria, Santa Maria-RS, Brazil.
da Silva Sangoi M
No affiliation info available
da Silva LM
No affiliation info available
Todeschini V
No affiliation info available
Dalmora SL
No affiliation info available

MeSH

AnimalsChromatography, Micellar Electrokinetic CapillaryCyproheptadineDrug StabilityL CellsMiceMolecular StructurePharmaceutical PreparationsReproducibility of ResultsSensitivity and SpecificityTabletsTime Factors

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

18693320

Citation

Nogueira, Daniele Rubert, et al. "Determination of Rupatadine in Pharmaceutical Formulations By a Validated Stability-indicating MEKC Method." Journal of Separation Science, vol. 31, no. 16-17, 2008, pp. 3098-105.
Nogueira DR, da Silva Sangoi M, da Silva LM, et al. Determination of rupatadine in pharmaceutical formulations by a validated stability-indicating MEKC method. J Sep Sci. 2008;31(16-17):3098-105.
Nogueira, D. R., da Silva Sangoi, M., da Silva, L. M., Todeschini, V., & Dalmora, S. L. (2008). Determination of rupatadine in pharmaceutical formulations by a validated stability-indicating MEKC method. Journal of Separation Science, 31(16-17), 3098-105. https://doi.org/10.1002/jssc.200800254
Nogueira DR, et al. Determination of Rupatadine in Pharmaceutical Formulations By a Validated Stability-indicating MEKC Method. J Sep Sci. 2008;31(16-17):3098-105. PubMed PMID: 18693320.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of rupatadine in pharmaceutical formulations by a validated stability-indicating MEKC method. AU - Nogueira,Daniele Rubert, AU - da Silva Sangoi,Maximiliano, AU - da Silva,Lucélia Magalhães, AU - Todeschini,Vítor, AU - Dalmora,Sérgio Luiz, PY - 2008/8/12/pubmed PY - 2008/12/20/medline PY - 2008/8/12/entrez SP - 3098 EP - 105 JF - Journal of separation science JO - J Sep Sci VL - 31 IS - 16-17 N2 - 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 microm 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 degrees 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 microg/mL (r2=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 microg/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). SN - 1615-9314 UR - https://www.unboundmedicine.com/medline/citation/18693320/Determination_of_rupatadine_in_pharmaceutical_formulations_by_a_validated_stability_indicating_MEKC_method_ L2 - https://doi.org/10.1002/jssc.200800254 DB - PRIME DP - Unbound Medicine ER -