Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid

A method based on single column ion chromatography with UV detection was developed for purity testing and assay of monosodium olpadronate. The analyte aqueous solution is precipitated with methanol to enhance the impurities/olpadronate molar ratio, thus improving purity determination at trace levels...

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Guardado en:
Detalles Bibliográficos
Publicado: 2001
Materias:
Bisphosphonate analysis
HPLC
Impurities
Ion chromatography
Olpadronate
chloride
mesylic acid
nitric acid
olpadronic acid
phosphate
phosphite
accuracy
conference paper
drug formulation
drug impurity
drug purity
ion exchange chromatography
priority journal
Chlorides
Chromatography, Ion Exchange
Diphosphonates
Mesylates
Phosphates
Phosphites
Sensitivity and Specificity
Spectrophotometry, Ultraviolet
Acceso en línea:https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_07317085_v24_n5-6_p1011_Quattrocchi
http://hdl.handle.net/20.500.12110/paper_07317085_v24_n5-6_p1011_Quattrocchi
Aporte de:
Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) de Universidad de Buenos Aires
id paper:paper_07317085_v24_n5-6_p1011_Quattrocchi
record_format dspace
spelling paper:paper_07317085_v24_n5-6_p1011_Quattrocchi2023-06-08T15:43:52Z Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid Bisphosphonate analysis HPLC Impurities Ion chromatography Olpadronate chloride mesylic acid nitric acid olpadronic acid phosphate phosphite accuracy conference paper drug formulation drug impurity drug purity ion exchange chromatography priority journal Chlorides Chromatography, Ion Exchange Diphosphonates Mesylates Phosphates Phosphites Sensitivity and Specificity Spectrophotometry, Ultraviolet A method based on single column ion chromatography with UV detection was developed for purity testing and assay of monosodium olpadronate. The analyte aqueous solution is precipitated with methanol to enhance the impurities/olpadronate molar ratio, thus improving purity determination at trace levels. The resulting solution is injected into a standard chromatographic system with UV detector in indirect mode with a Waters IC Pak HR column using diluted nitric acid as the mobile phase. The method was fully validated according to ICH guidelines for the determination of phosphite, phosphate, chloride and methanesulfonic acid in olpadronate being suitable for purity testing and assay. © 2001 Elsevier Science B.V. 2001 https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_07317085_v24_n5-6_p1011_Quattrocchi http://hdl.handle.net/20.500.12110/paper_07317085_v24_n5-6_p1011_Quattrocchi
institution Universidad de Buenos Aires
institution_str I-28
repository_str R-134
collection Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA)
topic Bisphosphonate analysis
HPLC
Impurities
Ion chromatography
Olpadronate
chloride
mesylic acid
nitric acid
olpadronic acid
phosphate
phosphite
accuracy
conference paper
drug formulation
drug impurity
drug purity
ion exchange chromatography
priority journal
Chlorides
Chromatography, Ion Exchange
Diphosphonates
Mesylates
Phosphates
Phosphites
Sensitivity and Specificity
Spectrophotometry, Ultraviolet
spellingShingle Bisphosphonate analysis
HPLC
Impurities
Ion chromatography
Olpadronate
chloride
mesylic acid
nitric acid
olpadronic acid
phosphate
phosphite
accuracy
conference paper
drug formulation
drug impurity
drug purity
ion exchange chromatography
priority journal
Chlorides
Chromatography, Ion Exchange
Diphosphonates
Mesylates
Phosphates
Phosphites
Sensitivity and Specificity
Spectrophotometry, Ultraviolet
Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
topic_facet Bisphosphonate analysis
HPLC
Impurities
Ion chromatography
Olpadronate
chloride
mesylic acid
nitric acid
olpadronic acid
phosphate
phosphite
accuracy
conference paper
drug formulation
drug impurity
drug purity
ion exchange chromatography
priority journal
Chlorides
Chromatography, Ion Exchange
Diphosphonates
Mesylates
Phosphates
Phosphites
Sensitivity and Specificity
Spectrophotometry, Ultraviolet
description A method based on single column ion chromatography with UV detection was developed for purity testing and assay of monosodium olpadronate. The analyte aqueous solution is precipitated with methanol to enhance the impurities/olpadronate molar ratio, thus improving purity determination at trace levels. The resulting solution is injected into a standard chromatographic system with UV detector in indirect mode with a Waters IC Pak HR column using diluted nitric acid as the mobile phase. The method was fully validated according to ICH guidelines for the determination of phosphite, phosphate, chloride and methanesulfonic acid in olpadronate being suitable for purity testing and assay. © 2001 Elsevier Science B.V.
title Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
title_short Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
title_full Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
title_fullStr Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
title_full_unstemmed Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
title_sort ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid
publishDate 2001
url https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_07317085_v24_n5-6_p1011_Quattrocchi
http://hdl.handle.net/20.500.12110/paper_07317085_v24_n5-6_p1011_Quattrocchi
_version_ 1768543660933120000

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