Cargando…

A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil

The present study describes the development of a validated RP-HPLC method for the determination of 5-fluorouracil in presence of its degradation products or other pharmaceutical excipients. Stress studies were performed on 5-fluorouracil and it was found that it degrades sufficiently in alkaline con...

Descripción completa

Detalles Bibliográficos
Autores principales: Sinha, V. R., Kumar, R. V., Bhinge, J. R.
Formato: Texto
Lenguaje:English
Publicado: Medknow Publications 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2846467/
https://www.ncbi.nlm.nih.gov/pubmed/20376215
http://dx.doi.org/10.4103/0250-474X.59544
_version_ 1782179478250717184
author Sinha, V. R.
Kumar, R. V.
Bhinge, J. R.
author_facet Sinha, V. R.
Kumar, R. V.
Bhinge, J. R.
author_sort Sinha, V. R.
collection PubMed
description The present study describes the development of a validated RP-HPLC method for the determination of 5-fluorouracil in presence of its degradation products or other pharmaceutical excipients. Stress studies were performed on 5-fluorouracil and it was found that it degrades sufficiently in alkaline conditions, while negligible degradation was observed in acidic, neutral, oxidative and photolytic conditions. The peaks of the degradation products were not observed in the chromatogram due to the nonchromophoric nature of the degradation moiety formed. The separations were carried out on a C-18 reversed phase column (Phenomenex; Prodigy ODS3V, 250×4.6 mm, 5 μ) using 50mM KH(2)PO(4) (pH, 5.0) as mobile phase at a flow rate of 1.2 ml/min and temperature of 30°. The wavelength of detection was 254 nm. A retention time of nearly 6 minutes was obtained. Analytical validation parameters such as specificity and selectivity, linearity, accuracy and precision were evaluated. The calibration curve for 5-fluorouracil was linear (r(2)=0.999±0.0005) from range of 10 μg/ml to 100 μg/ml. Relative standard deviation values for all the key parameters, was less than 2.0 %. The recovery of the drug after standard addition to the degraded sample was found to be 104.69%. Thus, the developed RP-HPLC method was found to be suitable for the determination of 5-fluorouracil in bulk as well as stability samples of the pharmaceutical dosage forms containing various excipients.
format Text
id pubmed-2846467
institution National Center for Biotechnology Information
language English
publishDate 2009
publisher Medknow Publications
record_format MEDLINE/PubMed
spelling pubmed-28464672010-04-06 A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil Sinha, V. R. Kumar, R. V. Bhinge, J. R. Indian J Pharm Sci Research Paper The present study describes the development of a validated RP-HPLC method for the determination of 5-fluorouracil in presence of its degradation products or other pharmaceutical excipients. Stress studies were performed on 5-fluorouracil and it was found that it degrades sufficiently in alkaline conditions, while negligible degradation was observed in acidic, neutral, oxidative and photolytic conditions. The peaks of the degradation products were not observed in the chromatogram due to the nonchromophoric nature of the degradation moiety formed. The separations were carried out on a C-18 reversed phase column (Phenomenex; Prodigy ODS3V, 250×4.6 mm, 5 μ) using 50mM KH(2)PO(4) (pH, 5.0) as mobile phase at a flow rate of 1.2 ml/min and temperature of 30°. The wavelength of detection was 254 nm. A retention time of nearly 6 minutes was obtained. Analytical validation parameters such as specificity and selectivity, linearity, accuracy and precision were evaluated. The calibration curve for 5-fluorouracil was linear (r(2)=0.999±0.0005) from range of 10 μg/ml to 100 μg/ml. Relative standard deviation values for all the key parameters, was less than 2.0 %. The recovery of the drug after standard addition to the degraded sample was found to be 104.69%. Thus, the developed RP-HPLC method was found to be suitable for the determination of 5-fluorouracil in bulk as well as stability samples of the pharmaceutical dosage forms containing various excipients. Medknow Publications 2009 /pmc/articles/PMC2846467/ /pubmed/20376215 http://dx.doi.org/10.4103/0250-474X.59544 Text en © Indian Journal of Pharmaceutical Sciences http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Paper
Sinha, V. R.
Kumar, R. V.
Bhinge, J. R.
A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title_full A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title_fullStr A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title_full_unstemmed A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title_short A Stability-Indicating RP-HPLC Assay Method for 5-Fluorouracil
title_sort stability-indicating rp-hplc assay method for 5-fluorouracil
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2846467/
https://www.ncbi.nlm.nih.gov/pubmed/20376215
http://dx.doi.org/10.4103/0250-474X.59544
work_keys_str_mv AT sinhavr astabilityindicatingrphplcassaymethodfor5fluorouracil
AT kumarrv astabilityindicatingrphplcassaymethodfor5fluorouracil
AT bhingejr astabilityindicatingrphplcassaymethodfor5fluorouracil
AT sinhavr stabilityindicatingrphplcassaymethodfor5fluorouracil
AT kumarrv stabilityindicatingrphplcassaymethodfor5fluorouracil
AT bhingejr stabilityindicatingrphplcassaymethodfor5fluorouracil