Analysis of pharmaceuticals by capillary electrophoresis:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Braunschweig [u.a.]
Vieweg
1998
|
| Schriftenreihe: | Chromatographia CE series
2 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XII, 285 S. graph. Darst. |
| ISBN: | 3528066962 |
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| 245 | 1 | 0 | |a Analysis of pharmaceuticals by capillary electrophoresis |c Kevin D. Altria |
| 264 | 1 | |a Braunschweig [u.a.] |b Vieweg |c 1998 | |
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| 650 | 7 | |a Électrophorèse capillaire |2 ram | |
| 650 | 4 | |a Capillary electrophoresis | |
| 650 | 4 | |a Chemistry, Pharmaceutical |x methods | |
| 650 | 4 | |a Drugs |x Analysis | |
| 650 | 4 | |a Electrophoresis, Capillary |x methods | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis | |
| 650 | 4 | |a Pharmaceutical chemistry | |
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Datensatz im Suchindex
| _version_ | 1804126510924169216 |
|---|---|
| adam_text | ) - - /- - KEVIN D. ALTRIA ANALYSIS OF PHARMACEUTICALS BY CAPILLARY
ELECTROPHORESIS VIEWEG VII CONTENTS PREFACE V CONTENTS VII 1
INTRODUCTION TO CE AND THE USE OF CE IN PHARMACEUTICAL ANALYSIS 1 1.1
CAPILLARY ELECTROPHORESIS (CE) THEORY AND BACKGROUND 1 1.2 CE
INSTRUMENTATION 3 1.2.1 CAPILLARIES 3 1.2.2 TEMPERATURE CONTROL 3 1.2.3
SAMPLE INTRODUCTION 3 1.2.4 DETECTORS 3 1.3 BAND BROADENING EFFECTS IN
CE 4 1.3.1 HEAT DISSIPATION 4 1.3.2 ELECTROENDOSMOTIC FLOW 4 1.3.3
ON-CAPILLARY DETECTION 5 1.3.4 MOLECULAR DIFFUSION 6 1.3.5 INJECTION
RELATED BROADENING 6 1.4 SEPARATION MODES AVAILABLE 6 1.4.1 FREE
SOLUTION CAPILLARY ELECTROPHORESIS (FSCE) 6 1.4.2 MICELLAR
ELECTROKINETIC CAPILLARY CHROMATOGRAPHY (MECC) 9 1.4.3 CAPILLARY GEL
ELECTROPHORESIS (CGE) 11 1.4.4 CAPILLARY ISOELECTRIC FOCUSING (CIEF) 13
1.4.5 CAPILLARY ELECTROCHROMATOGRAPHY (CEC) 13 1.5 APPLICATION OF CE TO
SPECIFIC DRUG CLASSES 14 1.6 THE ROLE OF CE IN PHARMACEUTICAL ANALYSIS
16 REFERENCES 18 2 MAIN COMPONENT ASSAY BY CE 21 2.1 INTRODUCTION 21 2.2
REPORTED APPLICATIONS 21 2.2.1 LOW PH 23 2.2.2 HIGH PH 27 2.2.3 MECC 30
2.4 IDENTITY CONFIRMATION TESTING 33 2.5 GENERAL CONSIDERATIONS IN
QUANTITATIVE ANALYSIS 33 2.5.1 PRECISION 33 2.5.2 ACCURACY 38 2.5.3
LINEARITY 39 2.6 COMPARISON OF CE AND HPLC FOR DRUG ASSAY 39 REFERENCES
40 3 DETERMINATION OF DRUG RELATED IMPURITIES 44 3.1 INTRODUCTION 44 3.2
SEPARATIONS USING LOW PH ELECTROLYTES 49 3.3 HIGH PH 52 VIII CONTENTS
3.4 MECC 54 3.5 COMPARISON WITH HPLC 55 3.5.1 SENSITIVITY 56 3.6 PEAK
IDENTITY CONFIRMATION 57 3.7 APPLICATIONS 59 3.7.1 CHEMICAL PURITY
TESTING OF DRUG SUBSTANCE 61 3.7.2 CHEMICAL PURITY TESTING OF FORMULATED
PRODUCT 62 3.7.3 STABILITY TESTING 65 3.7.4 IMPURITY PROFILING 66
REFERENCES 66 4 SEPARATION AND QUANTITATION OF ENANTIOMERS 70 4.1
INTRODUCTION 70 4.2 CYCLODEXTRINS 70 4.2.1 LOW PH ELECTROLYTES
CONTAINING CYCLODEXTRINS 77 4.2.2 CYCLODEXTRINS AT HIGH PH 77 4.2.3
CYCLODEXTRINS IN NON-AQUEOUS CE 79 4.3 CROWN ETHERS 79 4.3.1 CROWN
ETHERS IN NON-AQUEOUS CE 79 4.4 SDS-CD MECC 80 4.5 CARBOHYDRATES 80 4.6
PROTEINS 80 4.7 BILE SALT MECC 81 4.8 ANTIBIOTICS 81 4.9 SYNTHETIC
SURFACTANTS 82 4.10 METHOD DEVELOPMENT 83 4.10.1 SELECTOR TYPE 83 4.10.2
TEMPERATURE 85 4.10.3 ELECTROLYTE SELECTION 85 4.10.4 MECC ELECTROLYTE
OPTIMISATION 86 4.11 QUANTITATIVE APPLICATIONS 86 4.11.1 ENANTIOMERIC
PURITY TESTING 87 4.11.2 REACTION RATE MONITORING 88 4.11.3 FORMULATION
STABILITY TESTING 88 4.11.4 CLINICAL APPLICATIONS 89 4.12 METHOD
VALIDATION 89 4.12.1 DETECTION LIMITS 89 4.12.2 PRECISION 90 4.12.3
LINEARITY 90 4.12.4 RECOVERY 91 4.12.5 CROSS-VALIDATION 91 4.12.6
FREEDOM FROM INTERFERENCE 91 4.12.7 SELECTIVITY 92 4.12.8 ROBUSTNESS
EVALUATION 92 4.12.9 METHOD TRANSFER 92 4.13 CONCLUSIONS 93 STOP PRESS
UPDATE 93 REFERENCES 94 IX 5 DETERMINATIONS OF DRUG COUNTER-IONS AND
IONIC IMPURITIES BY CE 101 5.1 INTRODUCTION 101 5.2 SEPARATION OF
INORGANIC ANIONS 103 5.2.1 INDIRECT DETECTION OF ANIONS 104 5.2.2 DIRECT
DETECTION OF ANIONS 105 5.3 METAL ION DETERMINATIONS 106 5.3.1
DETERMINATION OF METAL ION CONTENT BY INDIRECT UV DETECTION 106 5.3.2
DIRECT UV DETECTION OF METAL ION COMPLEXES 108 5.4 QUANTITATIVE
PROCEDURES 109 5.5 DETERMINATION OF INORGANIC ANION COUNTER-ION LEVELS
IN BASIC DRUGS 109 5.6 DETERMINATION OF ORGANIC ACID ANION COUNTER-ION
LEVELS IN BASIC DRUGS 109 5.7 QUANTITATION OF METAL COUNTER-ION LEVELS
IN ACIDIC DRUGS 113 5.8 DETERMINATION OF IONIC CONTAMINANTS IN DRUG
SUBSTANCE 116 5.9 BENEFITS AND DISADVANTAGES OF CE METHODS IN
STOICHIOMETRIC ANALYSIS 118 5.9.1 DISADVANTAGES 118 5.9.2 ADVANTAGES 118
REFERENCES 119 6 TRACE ANALYSIS AND RESIDUES DETERMINATION 121 6.1
INTRODUCTION 121 6.2 DRUG RESIDUE ANALYSIS 121 6.2.1 BASIC DRUGS
RESIDUES 123 6.2.2 ACIDIC DRUG RESIDUES 126 6.3 DETERGENT SOLUTION
RESIDUE ANALYSIS 127 6.3.1 SURFACTANT RESIDUES 127 6.3.2 METAL ION
RESIDUES FROM DETERGENT SOLUTIONS 128 6.3.3 EDTA RESIDUES 129 6.4 DRUG
DOPING LEVELS 130 6.5 ENVIRONMENTAL ANALYSIS 130 6.6 ADVANTAGES AND
DISADVANTAGES OF THE USE OF CE IN RESIDUES ANALYSIS 130 6.6.1
DISADVANTAGES 130 6.6.2 ADVANTAGES 130 REFERENCES 131 7 PHARMACEUTICAL
RAW MATERIALS AND EXCIPIENTS ANALYSIS 133 7.1 INTRODUCTION 133 7.2
ALCOHOLS 135 7.3 CARBOHYDRATES 136 7.4 CYCLODEXTRINS 137 7.5 DYES 137
7.6 FATTY ACIDS 137 7.7 FLAVOURING AGENTS 138 7.8 INORGANIC ANIONS 139
7.9 LECITHINS 140 7.10 METAL IONS 140 7.11 ORGANIC ACIDS 141
7.12POLYCARBOXYLIC ACIDS 142 7.13 PRESERVATIVES 142 CONTENTS 7.14
STARTING MATERIALS 144 7.15 SURFACTANTS 145 7.16 WATER PURITY 148
REFERENCES 149 8 ANALYSIS OF DISSOLUTION TEST SAMPLE SOLUTIONS 153 8.1
INTRODUCTION 153 8.2 TOTAL DRUG CONTENT RELEASE TESTING 154 8.3
DISSOLUTION PROFILE MONITORING 156 8.4 MONITORING OF THE DISSOLUTION OF
CHIRAL DRUGS 157 8.5 MULTI-COMPONENT ANALYSIS 159 8.6 BENEFITS AND
DISADVANTAGES OF ADOPTING CE FOR DISSOLUTION ANALYSIS 159 REFERENCES 160
9 DETERMINATION OF VITAMINS BY CAPILLARY ELECTROPHORESIS 162 9.1
INTRODUCTION 162 9.2 ASSAY 165 9.3 RELATED IMPURITIES DETERMINATIONS 169
9.4 CLINICAL DETERMINATIONS 169 9.5 IDENTITY CONFIRMATION 169 9.6
MICROEMULSION ELECTROKINETIC CAPILLARY CHROMATOGRAPHY (MEEKC) 170 9.7
CONCLUSIONS 171 REFERENCES 171 10 OVERVIEW OF APPLICATION OF CE TO
DETERMINE DRUGS IN BIOFLUIDS 173 10.1 INTRODUCTION 173 10.2 SAMPLE
PRETREATMENT PROCEDURES 173 10.3 DIRECT SAMPLE INJECTION 177 10.4 SAMPLE
MATRIX EFFECTS 179 10.5 SENSITIVITY ENHANCEMENT 179 10.6 QUANTITATIVE
PRECISION 181 10.7 APPLICATIONS 181 10.8 CHIRAL CLINICAL APPLICATIONS
185 10.9 NON-AQUEOUS CE AND CEC CLINICAL APPLICATIONS 186 REFERENCES 188
11 METHOD VALIDATION 193 11.1 INTRODUCTION 193 11.2 SPECIFIC METHOD
VALIDATION ASPECTS 193 11.2.1 SPECIFICITY (SELECTIVITY) 193 11.2.2
LINEARITY 195 11.2.3 SENSITIVITY 196 11.2.4 ACCURACY/RECOVERY 196 11.2.5
INJECTION REPEATABILITY 197 11.2.6 METHOD REPEATABILITY 199 1.2.7 METHOD
ROBUSTNESS 200 11.2.8 CROSS-VALIDATION 200 1.2.9 SOLUTION STABILITY 200
11.3 RESPONSE FACTORS 201 11.4 PEAK HOMOGENEITY 202 XI 11.5 METHOD
TRANSFER 203 11.6 SYSTEM SUITABILITY 203 11.7 CONCLUSIONS 203 REFERENCES
204 12 CAPILLARY ELECTROCHROMATOGRAPHY 206 12.1 INTRODUCTION 206 12.2
CEC INSTRUMENTATION 206 12.3 CEC OPERATION 208 12.4 DETECTION OPTIONS IN
CEC 210 12.5 ANALYTICAL PERFORMANCE OF CEC 211 12.6 APPLICATIONS 213
12.6.1 PHARMACEUTICAL APPLICATIONS 213 12.7 CHIRAL CEC 215 12.8 BENEFITS
AND DISADVANTAGES OF CEC COMPARED TO CE AND HPLC 216 12.8.1 ADVANTAGES
OF CEC 216 12.8.2 CURRENT DISADVANTAGES OF CEC 218 12.9 CONCLUSIONS 219
STOP PRESS UPDATE 219 REFERENCES 220 13 USE OF NON-AQUEOUS ELECTROLYTES
IN PHARMACEUTICAL ANALYSIS 223 13.1 INTRODUCTION 223 13.2 BASIC DRUGS
224 13.3 ACIDIC DRUGS 227 13.4 IMPURITY/METABOLITES DETERMINATIONS 227
13.5 CHIRAL SEPARATIONS 227 13.6EXCIPIENTS AND RAW MATERIALS 230 13.7
MAIN COMPONENT ASSAY 230 13.8 INORGANIC IONS AND SMALL ORGANIC IONS 232
13.9 PRACTICALITIES OF ROUTINE NACE OPERATION 233 13.10 COMPARISON OF
THE ADVANTAGES OF NACE AND AQUEOUS CE 234 REFERENCES 234 14 THE USE OF
CHEMOMETRICS AND EXPERIMENTAL DESIGNS IN CE METHOD DEVELOPMENT AND
ROBUSTNESS TESTING 236 14.1 INTRODUCTION 236 14.1.1 FULL AND FRACTIONAL
FACTORIAL DESIGNS 238 14.1.2 CENTRAL COMPOSITE AND OVERLAPPING
RESOLUTION MAPPING DESIGNS 238 14.1.3 SIMPLEX OPTIMISATION 238 14.2 MECC
METHOD DEVELOPMENT 239 14.3 FSCE METHOD DEVELOPMENT 240 14.4 CHIRAL CE
METHOD DEVELOPMENT 242 14.5 CEC METHOD DEVELOPMENT 243 14.6 ROBUSTNESS
TESTING 244 14.7 PEAK IDENTIFICATION 247 14.8 SELECTION OF EXPERIMENTAL
DESIGN 248 REFERENCES 248 XII CONTENTS 15 FORENSIC APPLICATIONS OF CE
251 15.1 INTRODUCTION 251 15.2 IDENTITY CONFIRMATION 251 15.3 ASSAY 251
15.4 CLINICAL APPLICATIONS 254 15.5 PURITY DETERMINATION 256 15.6
INORGANIC IONS 258 15.7 NON-AQUEOUS CE 259 15.8 CHIRAL 260 REFERENCES
261 16 DETERMINATION OF RADIOACTIVE COMPOUNDS BY CE 263 16.1
INTRODUCTION 263 16.2 RADIOACTIVITY DETECTORS 264 16.3
RADIOPHARMACEUTICAL PURITY AND ASSAY DETERMINATIONS 266 REFERENCES 267
17 MISCELLANEOUS PHARMACEUTICAL ANALYSIS RELATED AREAS OF CE 269 17.1
DRUG DIET DETERMINATIONS 269 17.2 REGULATORY ASPECTS 269 17.3
BIOPHARMACEUTICALS 271 17.3.1 PROTEINS 271 17.3.2 PEPTIDES 273 17.3.3
OLIGONUCLEOTIDES 274 17.4 COMBINATORIAL LIBRARIES 274 17.5
PHYSICOCHEMICAL PROPERTY DETERMINATIONS USING CE 275 17.5.1 BINDING
CONSTANTS 275 17.5.2 DISSOCIATION CONSTANTS 276 17.5.3 PARTITION
COEFFICIENTS 276 17.5.4 ISOELECTRIC POINT DETERMINATIONS 277 REFERENCES
277 SUBJECT INDEX 280
|
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| id | DE-604.BV011923180 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:18:36Z |
| institution | BVB |
| isbn | 3528066962 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-008059467 |
| oclc_num | 39728129 |
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| physical | XII, 285 S. graph. Darst. |
| publishDate | 1998 |
| publishDateSearch | 1998 |
| publishDateSort | 1998 |
| publisher | Vieweg |
| record_format | marc |
| series | Chromatographia CE series |
| series2 | Chromatographia CE series |
| spelling | Altria, Kevin D. Verfasser aut Analysis of pharmaceuticals by capillary electrophoresis Kevin D. Altria Braunschweig [u.a.] Vieweg 1998 XII, 285 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Chromatographia CE series 2 Médicaments - Analyse ram Électrophorèse capillaire ram Capillary electrophoresis Chemistry, Pharmaceutical methods Drugs Analysis Electrophoresis, Capillary methods Pharmaceutical Preparations analysis Pharmaceutical chemistry Arzneimittelanalyse (DE-588)4003116-0 gnd rswk-swf Kapillarelektrophorese (DE-588)4290002-5 gnd rswk-swf Arzneimittelanalyse (DE-588)4003116-0 s Kapillarelektrophorese (DE-588)4290002-5 s DE-604 Chromatographia CE series 2 (DE-604)BV011568238 2 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008059467&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Altria, Kevin D. Analysis of pharmaceuticals by capillary electrophoresis Chromatographia CE series Médicaments - Analyse ram Électrophorèse capillaire ram Capillary electrophoresis Chemistry, Pharmaceutical methods Drugs Analysis Electrophoresis, Capillary methods Pharmaceutical Preparations analysis Pharmaceutical chemistry Arzneimittelanalyse (DE-588)4003116-0 gnd Kapillarelektrophorese (DE-588)4290002-5 gnd |
| subject_GND | (DE-588)4003116-0 (DE-588)4290002-5 |
| title | Analysis of pharmaceuticals by capillary electrophoresis |
| title_auth | Analysis of pharmaceuticals by capillary electrophoresis |
| title_exact_search | Analysis of pharmaceuticals by capillary electrophoresis |
| title_full | Analysis of pharmaceuticals by capillary electrophoresis Kevin D. Altria |
| title_fullStr | Analysis of pharmaceuticals by capillary electrophoresis Kevin D. Altria |
| title_full_unstemmed | Analysis of pharmaceuticals by capillary electrophoresis Kevin D. Altria |
| title_short | Analysis of pharmaceuticals by capillary electrophoresis |
| title_sort | analysis of pharmaceuticals by capillary electrophoresis |
| topic | Médicaments - Analyse ram Électrophorèse capillaire ram Capillary electrophoresis Chemistry, Pharmaceutical methods Drugs Analysis Electrophoresis, Capillary methods Pharmaceutical Preparations analysis Pharmaceutical chemistry Arzneimittelanalyse (DE-588)4003116-0 gnd Kapillarelektrophorese (DE-588)4290002-5 gnd |
| topic_facet | Médicaments - Analyse Électrophorèse capillaire Capillary electrophoresis Chemistry, Pharmaceutical methods Drugs Analysis Electrophoresis, Capillary methods Pharmaceutical Preparations analysis Pharmaceutical chemistry Arzneimittelanalyse Kapillarelektrophorese |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008059467&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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