DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST

A simple, specific, precise and accurate simultaneous high-performance thin-layer chromatographic method of analysis for hydrocortisone and clotrimazole was developed and validated. The method employed HPTLC glass plates (20x10) mm precoated with silica gel 60 F254 as the stationary phase. The solve...

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Autores principales: Genete,Getachew, Hymete,Ariaya, Ahmed Bekhit,Adnan
Lenguaje:English
Publicado: Sociedad Chilena de Química 2012
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300001
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spelling oai:scielo:S0717-970720120003000012019-02-19DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TESTGenete,GetachewHymete,AriayaAhmed Bekhit,Adnan Hydrocortisone Clotrimazole HPTLC method Validation Stability indicating A simple, specific, precise and accurate simultaneous high-performance thin-layer chromatographic method of analysis for hydrocortisone and clotrimazole was developed and validated. The method employed HPTLC glass plates (20x10) mm precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of Toluene: Propanol: Ammonia (13:3:0.1v/v) that gave compact spots with Rf value of 0.27 ± 0.01 and 0.58 ± 0.02 for hydrocortisone and clotrimazole, respectively. Densitometric analysis of hydrocortisone and clotrimazole was carried out in the absorbance/reflectance mode at 226nm. The calibration curves showed good linear relationship with R² = 0.996 + 0.003 and 0.996 + 0.002 in the concentration range of 200-1200 and 200-1000 ng/ì! for hydrocortisone and clotrimazole, respectively. The method was validated for precision, recovery and robustness. The LOD & LOQ were found to be 35.31, 107.01 and 34.93, 105.87 ng/ì! for hydrocortisone and clotrimazole respectively. Statistical analysis proved that the method is repeatable, specific and accurate for the estimation of the studied drugs. Resolution of hydrocortisone, clotrimazole and their degradation products formed under different stress conditions (acid-base hydrolysis, oxidation and thermal degradation) was successfully achieved with the developed method indicating that it can be employed as a stability indicating method.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.57 n.3 20122012-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300001en10.4067/S0717-97072012000300001
institution Scielo Chile
collection Scielo Chile
language English
topic Hydrocortisone
Clotrimazole
HPTLC method
Validation
Stability indicating
spellingShingle Hydrocortisone
Clotrimazole
HPTLC method
Validation
Stability indicating
Genete,Getachew
Hymete,Ariaya
Ahmed Bekhit,Adnan
DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
description A simple, specific, precise and accurate simultaneous high-performance thin-layer chromatographic method of analysis for hydrocortisone and clotrimazole was developed and validated. The method employed HPTLC glass plates (20x10) mm precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of Toluene: Propanol: Ammonia (13:3:0.1v/v) that gave compact spots with Rf value of 0.27 ± 0.01 and 0.58 ± 0.02 for hydrocortisone and clotrimazole, respectively. Densitometric analysis of hydrocortisone and clotrimazole was carried out in the absorbance/reflectance mode at 226nm. The calibration curves showed good linear relationship with R² = 0.996 + 0.003 and 0.996 + 0.002 in the concentration range of 200-1200 and 200-1000 ng/ì! for hydrocortisone and clotrimazole, respectively. The method was validated for precision, recovery and robustness. The LOD & LOQ were found to be 35.31, 107.01 and 34.93, 105.87 ng/ì! for hydrocortisone and clotrimazole respectively. Statistical analysis proved that the method is repeatable, specific and accurate for the estimation of the studied drugs. Resolution of hydrocortisone, clotrimazole and their degradation products formed under different stress conditions (acid-base hydrolysis, oxidation and thermal degradation) was successfully achieved with the developed method indicating that it can be employed as a stability indicating method.
author Genete,Getachew
Hymete,Ariaya
Ahmed Bekhit,Adnan
author_facet Genete,Getachew
Hymete,Ariaya
Ahmed Bekhit,Adnan
author_sort Genete,Getachew
title DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
title_short DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
title_full DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
title_fullStr DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
title_full_unstemmed DEVELOPMENT AND VALIDATION OF HPTLC ASSAY METHOD FOR SIMULTANEOUS QUANTIFICATION OF HYDROCORTISONE AND CLOTRIMAZOLE IN CREAM AND APPLYING FOR STABILITY INDICATING TEST
title_sort development and validation of hptlc assay method for simultaneous quantification of hydrocortisone and clotrimazole in cream and applying for stability indicating test
publisher Sociedad Chilena de Química
publishDate 2012
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300001
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AT ahmedbekhitadnan developmentandvalidationofhptlcassaymethodforsimultaneousquantificationofhydrocortisoneandclotrimazoleincreamandapplyingforstabilityindicatingtest
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