Development and Validation of a Spectrofluorimetric Method for the Quantification of Capecitabine in Bulk and Tablets

ObjectivesA new, simple, and affordable spectrofluorimetric method was established for quantification of capecitabine in bulk and in marketed formulations. Materials and MethodsNative fluorescence of capecitabine in 0.1% (w/v) cetrimide was measured at 386 nm after excitation at 313 nm. ResultsA lin...

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Published in:Turkish journal of pharmaceutical sciences 2023-08, Vol.20 (4), p.234-239
Main Authors: NARAPARAJU, Swathi, MUKTI, Ambati, ANUMOLU, Durga Panikumar, CHAGANTI, Soujanya
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container_end_page 239
container_issue 4
container_start_page 234
container_title Turkish journal of pharmaceutical sciences
container_volume 20
creator NARAPARAJU, Swathi
MUKTI, Ambati
ANUMOLU, Durga Panikumar
CHAGANTI, Soujanya
description ObjectivesA new, simple, and affordable spectrofluorimetric method was established for quantification of capecitabine in bulk and in marketed formulations. Materials and MethodsNative fluorescence of capecitabine in 0.1% (w/v) cetrimide was measured at 386 nm after excitation at 313 nm. ResultsA linear relationship between fluorescence intensity and capecitabine concentration was noticed in 0.2-1.0 μg/mL range. The method was supported by checking several validation parameters as stated using International Conference on Harmonization (ICH) guidelines. The limit of detection (LOD) and quantification (LOQ) values (0.032 and 0.096 μg/mL, respectively) and results of validation parameters demonstrated that the method procedure were sensitive, accurate, precise, and reproducible (% relative standard deviation
doi_str_mv 10.4274/tjps.galenos.2022.46364
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Materials and MethodsNative fluorescence of capecitabine in 0.1% (w/v) cetrimide was measured at 386 nm after excitation at 313 nm. ResultsA linear relationship between fluorescence intensity and capecitabine concentration was noticed in 0.2-1.0 μg/mL range. The method was supported by checking several validation parameters as stated using International Conference on Harmonization (ICH) guidelines. The limit of detection (LOD) and quantification (LOQ) values (0.032 and 0.096 μg/mL, respectively) and results of validation parameters demonstrated that the method procedure were sensitive, accurate, precise, and reproducible (% relative standard deviation &lt;2.0). The percentage assay in commercial formulation was found to be 99.2, which agrees with ICH guidelines. 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Materials and MethodsNative fluorescence of capecitabine in 0.1% (w/v) cetrimide was measured at 386 nm after excitation at 313 nm. ResultsA linear relationship between fluorescence intensity and capecitabine concentration was noticed in 0.2-1.0 μg/mL range. The method was supported by checking several validation parameters as stated using International Conference on Harmonization (ICH) guidelines. The limit of detection (LOD) and quantification (LOQ) values (0.032 and 0.096 μg/mL, respectively) and results of validation parameters demonstrated that the method procedure were sensitive, accurate, precise, and reproducible (% relative standard deviation &lt;2.0). The percentage assay in commercial formulation was found to be 99.2, which agrees with ICH guidelines. 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title Development and Validation of a Spectrofluorimetric Method for the Quantification of Capecitabine in Bulk and Tablets
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