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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Sociedad Chilena de Química
2012
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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 |
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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 |
work_keys_str_mv |
AT genetegetachew developmentandvalidationofhptlcassaymethodforsimultaneousquantificationofhydrocortisoneandclotrimazoleincreamandapplyingforstabilityindicatingtest AT hymeteariaya developmentandvalidationofhptlcassaymethodforsimultaneousquantificationofhydrocortisoneandclotrimazoleincreamandapplyingforstabilityindicatingtest AT ahmedbekhitadnan developmentandvalidationofhptlcassaymethodforsimultaneousquantificationofhydrocortisoneandclotrimazoleincreamandapplyingforstabilityindicatingtest |
_version_ |
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