STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS

ABSTRACT A stability-indicating LC method was developed and validated for the determination of risperidone in tablets. Quantitation was achieved by LC/DAD at 294 nm over the concentration range of 25.00 μg/mL to 250.00 μg/mL. Mobile phase was a mixture of water: glacial acetic acid...

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Autores principales: Mennickent,Sigrid, Diego,Marta de, Liser,Bernd, Trujillo,Lina
Lenguaje:English
Publicado: Sociedad Chilena de Química 2018
Materias:
LC
Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000304150
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spelling oai:scielo:S0717-970720180003041502018-10-03STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETSMennickent,SigridDiego,Marta deLiser,BerndTrujillo,Lina risperidone stability-indicating method LC tablets stress testing ABSTRACT A stability-indicating LC method was developed and validated for the determination of risperidone in tablets. Quantitation was achieved by LC/DAD at 294 nm over the concentration range of 25.00 μg/mL to 250.00 μg/mL. Mobile phase was a mixture of water: glacial acetic acid 0.50 %: triethylamine 0.80 %: acetonitrile (65.00: 0.32: 0.52: 34.16, v/v), using a Purosphere STAR RP-18e 250 × 4.5 mm (5μ) column, and paroxetine as internal standard. The method exhibited an adequate linearity (r = 0.999), selectivity, precision (RSD ≤ 0.847 %) and accuracy (recoveries from 99.55 % to 101.35 %). Risperidone was subjected to the stress conditions of oxidative, acid, base, thermal and photolytic degradation. Risperidone was found no degrade in basic or acid stress conditions, neither in thermal stress exposition (50, 70 and 100 °C) no at visible or UV stress conditions, during the time of the study. Only two degradation products were observed with peroxide oxidation, well resolved from analyte peak, proving the stability-indicating power of the method. The proposed method was found to be suitable for quantitative determination and the stability studies of risperidone in tablets.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.63 n.3 20182018-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000304150en10.4067/s0717-97072018000304150
institution Scielo Chile
collection Scielo Chile
language English
topic risperidone
stability-indicating method
LC
tablets
stress testing
spellingShingle risperidone
stability-indicating method
LC
tablets
stress testing
Mennickent,Sigrid
Diego,Marta de
Liser,Bernd
Trujillo,Lina
STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
description ABSTRACT A stability-indicating LC method was developed and validated for the determination of risperidone in tablets. Quantitation was achieved by LC/DAD at 294 nm over the concentration range of 25.00 μg/mL to 250.00 μg/mL. Mobile phase was a mixture of water: glacial acetic acid 0.50 %: triethylamine 0.80 %: acetonitrile (65.00: 0.32: 0.52: 34.16, v/v), using a Purosphere STAR RP-18e 250 × 4.5 mm (5μ) column, and paroxetine as internal standard. The method exhibited an adequate linearity (r = 0.999), selectivity, precision (RSD ≤ 0.847 %) and accuracy (recoveries from 99.55 % to 101.35 %). Risperidone was subjected to the stress conditions of oxidative, acid, base, thermal and photolytic degradation. Risperidone was found no degrade in basic or acid stress conditions, neither in thermal stress exposition (50, 70 and 100 °C) no at visible or UV stress conditions, during the time of the study. Only two degradation products were observed with peroxide oxidation, well resolved from analyte peak, proving the stability-indicating power of the method. The proposed method was found to be suitable for quantitative determination and the stability studies of risperidone in tablets.
author Mennickent,Sigrid
Diego,Marta de
Liser,Bernd
Trujillo,Lina
author_facet Mennickent,Sigrid
Diego,Marta de
Liser,Bernd
Trujillo,Lina
author_sort Mennickent,Sigrid
title STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
title_short STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
title_full STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
title_fullStr STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
title_full_unstemmed STABILITY INDICATING HPLC METHOD FOR QUANTIFICATION OF RISPERIDONE IN TABLETS
title_sort stability indicating hplc method for quantification of risperidone in tablets
publisher Sociedad Chilena de Química
publishDate 2018
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072018000304150
work_keys_str_mv AT mennickentsigrid stabilityindicatinghplcmethodforquantificationofrisperidoneintablets
AT diegomartade stabilityindicatinghplcmethodforquantificationofrisperidoneintablets
AT liserbernd stabilityindicatinghplcmethodforquantificationofrisperidoneintablets
AT trujillolina stabilityindicatinghplcmethodforquantificationofrisperidoneintablets
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