Quantification in LC and GC: a practical guide to good chromatographic data
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Weinheim
WILEY-VCH
2009
|
| Ausgabe: | [1. Aufl.] |
| Schlagworte: | |
| Online-Zugang: | Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | XVIII, 358 S. zahlr. graph. Darst. 1 CD-ROM (12 cm) |
| ISBN: | 9783527323012 |
Internformat
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Datensatz im Suchindex
| _version_ | 1805091947583373312 |
|---|---|
| adam_text |
Titel: Quantification in LC and GC
Autor: Kuss, Hans-Joachim
Jahr: 2009
|v
Contents
Preface XIII
List of Contributors XV
Structure of the Book XVII
Part 1 Evaluation and Estimation of Chromatographic Data 1
1 Evaluating Chromatograms 3
Hans-Joachim Kuss and Daniel Stauffer
1.1 Efficiency 4
1.2 EMG Model 5
1.3 Chromatogram 7
1.4 Selectivity 8
References 8
2 Integration Parameters 9
Daniel Stauffer and Hans-Joachim Kuss
2.1 Peak Recognition Methods 9
2.1.1 The Classical Method 9
2.1.2 Alternative Method 12
2.2 Integration and Integration Parameters 12
2.2.1 Data Acquisition and Integration with Empower 2 12
2.2.2 Data Acquisition and Integration with Chromeleon 14
2.2.3 Data Acquisition and Integration with EZChrom Elite 14
2.2 A Data Recording and Integration with ChemStation 16
3 Integration Errors 17
Hans-Joachim Kuss
3.1 What Does the Literature Say on Integration Errors? 17
3.2 Integration in Routine Practice 19
Quantification in LC and GO A Practical Guide to Good Chromatographic Data
Edited by Hans-Joachim Kuss and Stavros Kromidas
Copyright © 2009 WILEY-VCH Verlag GmbH Co. KGaA, Weinheim
ISBN: 978-3-527-32301-2
VII Contents
3.2.1 Integration, Simple and Automatically Feasible? 20
3.2.2 Comparison of Integration Systems with a Small Number of
Tall Peaks 20
3.2.3 Comparison of Integration Systems for Numerous Small Peaks 25
3.3 Chromatogram Simulation 28
3.3.1 Simulation of a Digital Chromatogram 29
3.3.1.1 One Peak 30
3.3.1.2 Several Peaks 32
3.3.1.3 Noise 32
3.3.1.4 Drift 33
3.3.1.5 Peak Area 34
3.3.1.6 Peaks Merged Together 34
3.3.1.7 Unclear Baseline 37
3.3.1.8 Tailing 37
3.3.1.9 Data Point Interval 37
3.3.1.10 Other Characteristic Quantities 43
3.3.1.11 Gas Chromatogram 44
3.3.1.12 Applications of the Simulation 45
3.3.2 Simulation of a Standard Curve 47
3.3.2.1 Tenfold Simulation at the Limit of Quantification 55
3.3.3 Simulation of an Isocratic Chromatogram 55
3.3.4 Simulation of a Gradient Chromatogram 63
3.3.5 By-Product Analysis 68
3.3.6 Post-Simulation of Real Chromatograms 78
References 82
4 Simulation of Chromatograms 83
Uwe D. Neue
4.1 Introduction 83
4.2 Peak Simulation 84
4.2.1 Symmetrical Peaks 84
4.2.2 Peak Tailing 85
4.3 The Baseline 88
4.4 The Chromatogram 89
4.5 Simple Retention Modeling and Real Chromatograms 91
4.5.1 Isocratic Chromatography 91
4.5.2 Gradient Chromatography 95
4.6 Outlook 102
References 103
5 Integration of Asymmetric Peaks 105
Hans-Joachim Kuss
5.1 The Valley Between Merged Peaks 108
5.2 Small Peak Between Larger Ones 110
5.3 Peak Pairs 232
Contents IVII
5.4 Simulation of a Calibration 113
5.5 Exponential Skim 117
5.6 Integration of Merged Peaks 120
5.7 Integration in Daily Practice 121
References 122
6 Deconvolution 123
Mike Hillebrand
6.1 Introduction 123
6.1.1 Software Applications for Deconvolution 126
6.2 Influences on Deconvolution 127
6.2.1 The Baseline Path 128
6.2.2 Peak Homogeneity-Number of Peaks 128
6.2.3 Noise 329
6.2.4 Peak Symmetry 129
6.3 Deconvolution of Gaussian-Shaped Peaks 129
6.3.1 Westerberg Report Simulation 132
6.4 Deconvolution of Peaks with Tailing 134
6.4.1 Peaks with Different Tailing 137
6.5 Deconvolution of Gradient Runs 141
6.5.1 Complex Baseline 141
6.6 Real Chromatogram 147
6.7 Outlook 149
References 150
7 Interpretation of Chromatograms 153
Hans-Joachim Kuss
7.1 Using the Peak Height 153
7.2 Evaluation 154
7.2.1 Evaluation Methods 155
7.3 Calibration 156
7.3.1 Linear Regression 157
7.3.2 Weighted Linear Regression 161
References 165
8 General Interpretation of Analytical Data 167
Joachim Ermer
8.1 (Normal) Distribution of Analytical Data 167
8.2 Problems of Prediction 171
8.3 Analytical Variability 174
8.3.1 Variability Contributions and Precision Levels 174
8.3.2 System or Injection Precision 176
8.3.3 Repeatability 178
S3 A Reproducibility 179
8.3.4.1 Number of Series 180
VIIII Contents
8.3.4.2 Analysis of Variances 180
8.3.4.3 Benchmarking for Reproducibility 182
8.3.5 Consequences for the Design of an Analytical Procedure 183
8.3.6 Concentration Dependence of the Precision 185
8.3.7 Conclusions 187
8.4 Key Points 188
References 188
9 Metrological Aspects of Chromatographic Data Evaluation 191
Ulrich Panne
9.1 Introduction 191
9.2 Measurement Uncertainty 193
9.3 Traceability of Analytical Measurements 205
References 208
Part 2 Characterization of the Evaluation of Different Chromatographic
Modes 211
10 Evaluation and Estimation of Chromatographic Data in CC 213
Werner Engewald (Translator: Mike Hillebrand)
10.1 Introduction 213
10.2 How Does GC Differ from HPLC? 214
10.2.1 What Consequences Result from These Differences? 215
10.2.1.1 Applicability of GC 215
10.2.1.2 Sample Injection 219
10.2.1.3 Column 219
10.2.1.4 Detector 221
10.2.1.5 Fast Gas Chromatography 222
10.3 Qualitative Analysis 223
10.3.1 Introductory Remarks 223
10.3.1.1 Fingerprint Analysis 223
10.3.1.2 Peak Purity 224
10.3.2 Comparison of Retention Times 225
10.3.3 Relative Retention Times 225
10.3.4 Retention Time Locking (RTL) 226
10.4 GC-MS Coupling 227
10.4.1 MS as an Identifying Detector (Scan Mode) 227
10.4.2 Use of Spectral Libraries 228
10.4.3 Spectrum Deconvolution 231
10.4.4 MS as a Mass-Selective Detector 233
10.4.4.1 Mass Fragmentography (Reconstructed or Extracted Ion
Chromatogram) 233
10.4.4.2 SIM (Single Ion Monitoring) or MID (Multiple Ion Recording) 234
10.4.5 Chemical Ionization 235
i
Contents IIX
10.5 Quantitative Analysis 236
10.5.1 Setting up an Analysis Sequence 236
10.6 Isotope Dilution Analysis (IDA) or Stable Isotope Dilution Analysis
(SIDA) 237
10.7 Matrix Effects in Trace Analysis 237
10.8 Headspace-GC 238
10.9 Estimation of the Correction Factor with the FID 239
References 241
11 Data Evaluation in LC-MS 243
Hartmut Kirchherr
11.1 Introduction 243
11.2 Influence of the Matrix in Chromatography 244
11.3 Internal Standards 252
11.4 Adjustments to the Mass Spectrometer 255
11.5 Evaluation Software 258
References 259
12 Evaluation of Chromatographic Data in Ion Chromatography 261
Heiko Herrmann and Detlefjensen
12.1 Introduction 261
12.2 Eluents 262
12.2.1 Purity 262
12.3 The Water Dip - the Solvent Peak in Ion Chromatography 263
12.4 Contaminants 266
12.5 Calibration Functions 268
References 268
13 Qualification of CPC/CFC/SEC Data and Results 271
Daniela Held and Peter KHz
13.1 Introduction 271
13.2 Principles of GPC/SEC Data Processing 272
13.2.1 Calculation of Molar Mass Averages 274
13.3 Guidelines, Standards and Requirements for GPC/SEC Data
Processing 277
13.4 Validation and Tests for GPC/SEC Data Evaluation 279
13.4.1 Description of a General Verification Procedure for GPC/SEC
Software 279
13.4.2 Validation of the Molar Mass Distribution Calculation 280
13.5 Influence of Data Processing, Calibration Methods and
Signal Quality on Accuracy and Precision of GPC/SEC
Results 284
13.5.1 Validation of GPC/SEC Evaluation with External Molar Mass
Calibration 284
13.5.2 Validation of GPC/SEC Evaluation with Viscometry Set-ups 285
X I Contents
13.5.3 Influence of Detector Noise on the Accuracy of GPC/SEC
Results 285
13.5.4 Influence of the Detector Drift on the Accuracy of
GPC/SEC Results 287
13.5.5 Influence of the Number of Data Points on the Accuracy of
GPC/SEC Results 288
13.6 Influence of GPC/SEC Specific Parameters on the Precision and
Accuracy of GPC/SEC Results 290
13.6.1 Influence of Parameters for GPC/SEC with External Molar Mass
Calibration 290
13.6.1.1 Influence of the Calibration Curve 290
13.6.1.2 Influence of Instrument Parameters (Instrument Performance) 294
13.6.1.3 Influence of Evaluation Parameters 295
13.6.2 Influence of Parameters for GPC/SEC with Light Scattering
Detection 297
13.6.2.1 Influence of Instrument Calibration 299
13.6.2.2 Influence of Instrument Performance 299
13.6.2.3 Influence of Evaluation Parameters 299
13.6.3 Repeatability and Reproducibility of GPC/SEC Analyses 299
13.7 Summary 301
References 302
Part 3 Requirements for Chromatographic Data Analysis from the
Viewpoint of Organisations and Public Authorities 303
14 The Science Behind the Pharmaceutical Regulatory Chromatographic
Procedures 305
Linda Ng
14.1 Introduction 305
14.2 Instrument Qualification 306
14.3 Chromatographic Procedures 307
14.4 Method Design, Development and Validation 309
14.5 Compendial Procedures 311
14.6 Conclusions 311
References 312
15 Interpretation of Chromatographic Data According to the
Pharmacopoeias - Control of Impurities 313
Ulrich Rose
15.1 Outline 313
15.2 Interpretation of Qualitative Data 313
15.2.1 System Suitability Test 316
15.3 Interpretation of Quantitative Data 318
References 320
I
Contents I XI
16 Requirements of (Chromatographic) Data in Pharmaceutical Analysis 321
Joachim Ermer
16.1 System Suitability Tests 321
16.1.1 European Pharmacopoeia (EP) 322
16.1.1.1 Chromatographic Parameters 325
16.1.1.2 Signal-to-Noise Ratio 326
16.1.1.3 System Precision 327
16.1.2 US Pharmacopoeia 328
16.1.3 FDA Reviewer Guidance 329
16.2 Acceptance Limits for the Specification and Precision 330
16.2.1 Assay 330
16.2.1.1 Based on the Method Capability Index 330
16.2.1.2 Based on the 95% Prediction Interval (DPhG-Approach) 331
16.2.2 Impurity Determination 332
16.2.2.1 Acceptance Limits of the Specification 332
16.2.2.2 Quantitation Limit and Variability 332
16.2.3 Key Points 332
16.3 Interpretation and Treatment of Analytical Data 333
16.3.1 Prerequisites 333
16.3.2 Measurement Principles and Variation 333
16.3.3 Outlying Results 334
16.3.3.1 Outlier Test According to Hampel 334
16.3.4 Comparison of Analytical Results 335
16.3.4.1 Precision 335
16.3.4.2 Accuracy 337
16.3.5 Key Points 338
References 338
17 Evaluation and Valuation of Chromatographic Data 341
Stavros Kromidas
17.1 Introduction 341
17.2 The Situation - or Why Does so Little Change? 341
17.3 How Can Something Change and When is it Really Necessary? 343
17.4 Who Can Change Something? 345
Index 347
Contents of the CD 357 |
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| spelling | Quantification in LC and GC a practical guide to good chromatographic data ed. by Hans-Joachim Kuss ... [1. Aufl.] Weinheim WILEY-VCH 2009 XVIII, 358 S. zahlr. graph. Darst. 1 CD-ROM (12 cm) txt rdacontent n rdamedia nc rdacarrier Gas chromatography Liquid chromatography Datenanalyse (DE-588)4123037-1 gnd rswk-swf Flüssigkeitschromatographie (DE-588)4017622-8 gnd rswk-swf Gaschromatographie (DE-588)4019330-5 gnd rswk-swf Flüssigkeitschromatographie (DE-588)4017622-8 s Datenanalyse (DE-588)4123037-1 s DE-604 Gaschromatographie (DE-588)4019330-5 s Kuss, Hans-Joachim Sonstige oth text/html http://deposit.dnb.de/cgi-bin/dokserv?id=3192263&prov=M&dok_var=1&dok_ext=htm Inhaltstext HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017135233&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Quantification in LC and GC a practical guide to good chromatographic data Gas chromatography Liquid chromatography Datenanalyse (DE-588)4123037-1 gnd Flüssigkeitschromatographie (DE-588)4017622-8 gnd Gaschromatographie (DE-588)4019330-5 gnd |
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| title | Quantification in LC and GC a practical guide to good chromatographic data |
| title_auth | Quantification in LC and GC a practical guide to good chromatographic data |
| title_exact_search | Quantification in LC and GC a practical guide to good chromatographic data |
| title_full | Quantification in LC and GC a practical guide to good chromatographic data ed. by Hans-Joachim Kuss ... |
| title_fullStr | Quantification in LC and GC a practical guide to good chromatographic data ed. by Hans-Joachim Kuss ... |
| title_full_unstemmed | Quantification in LC and GC a practical guide to good chromatographic data ed. by Hans-Joachim Kuss ... |
| title_short | Quantification in LC and GC |
| title_sort | quantification in lc and gc a practical guide to good chromatographic data |
| title_sub | a practical guide to good chromatographic data |
| topic | Gas chromatography Liquid chromatography Datenanalyse (DE-588)4123037-1 gnd Flüssigkeitschromatographie (DE-588)4017622-8 gnd Gaschromatographie (DE-588)4019330-5 gnd |
| topic_facet | Gas chromatography Liquid chromatography Datenanalyse Flüssigkeitschromatographie Gaschromatographie |
| url | http://deposit.dnb.de/cgi-bin/dokserv?id=3192263&prov=M&dok_var=1&dok_ext=htm http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017135233&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT kusshansjoachim quantificationinlcandgcapracticalguidetogoodchromatographicdata |