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Rapid Analysis of Chemical Drugs Using the Near-infrared Spectroscopic Technology



Chapter 1¡¡NIR Spectrometer¡¡/ 7

Classification and Characteristics of NIR Spectrometer¡¡/ 7

Key Performance Indicators of NIR Spectroscopic Instrument¡¡/ 11

Acquisition of NIR Spectrum¡¡/ 16

NIR Spectrometer in Mobile lab¡¡/ 17



Chapter 2¡¡Introduction Near-infrared Analysis Methods¡¡/ 20

Spectral Data Preprocessing Methods¡¡/ 21

Qualitative Analysis Method ¡¡/ 25

Cluster Analysis¡¡/ 31

Quantitative Analysis¡¡/ 35

Conformity Test Analysis¡¡/ 45

Correlation Coefficient Analysis¡¡/ 49

Methods of Model Transfer ¡¡/ 52



Chapter 3¡¡Application of NIR Methods in Drug Analysis¡¡/ 58

Analysis of Antibiotics Using NIR Methods¡¡/ 59

CASE STUDY 1¡¡ Establishment of Qualitative NIR Models for the Analysis of Cephalosporin Injection Powder Products¡¡/ 61

CASE STUDY 2¡¡ Rapid Determination of Cefuroxime Sodium Content Using NIR Analysis¡¡/ 66

CASE STUDY 3¡¡ Construction of a Universal NIR Model for Quantitative Analysis of Cefradine Capsules¡¡/ 73

CASE STUDY 4¡¡ Development of a Universal NIR Model for Quantitative Analysis of Phenoxymethylpenicillin Potassium Tablets¡¡/ 79

CASE STUDY 5¡¡ Universal NIR Models for the Quantitative Analysis of Ceftriaxone and Water Contents in Ceftriaxone Sodium Injection Products¡¡/ 85

Analysis of Chemical Drugs Using NIR Methods¡¡/ 96

CASE STUDY 6¡¡ Construction of a Quantitative Model for Simvastatin Tablets¡¡/ 98

CASE STUDY 7¡¡ NIR Models for Quantitative Analysis of Aminosalicylate and Water Contents in Sodium Aminosalicylate Injections¡¡/ 102

CASE STUDY 8¡¡ Rapid Analysis of Potassium Dehydroandrographolide Succinate Injection Using NIRDRS ¡¡/ 108

CASE STUDY 9¡¡ NIR Identification and Analysis of Compound Paracetamol and Amantadine Hydrochloride Tablets ¡¡/ 115

Application of NIR Spectroscopy in the Analysis of Traditional Chinese Medicines (TCM)¡¡/ 120

CASE STUDY 10¡¡ Establishment of a Qualitative NIR Model for Cortex Magnoliae officinalis¡¡/ 122

CASE STUDY 11¡¡ Analysis of Water Content in Liuwei Dihuang Pills Using NIR Spectroscopy¡¡/ 129

CASE STUDY 12¡¡ Qualitative Analysis of Different Brands of Jianwei Xiaoshi Tablets Using NIR Spectroscopy¡¡/ 131

CASE STUDY 13¡¡ Identification of Decoction Pieces of Common Yam Rhizome by NIR Method ¡¡/ 133

NIR Analysis of Illegal Additives in Medicinal Products¡¡/ 143

CASE STUDY 14¡¡ Illegal Addition of Sildenafil Citrate into Chinese Patent Medicine¡¡/ 144

CASE STUDY 15¡¡ Norfloxacin Addition in Lopermide Hydrochloride Capsules¡¡/ 146

CASE STUDY 16¡¡ NIR Correlation Analysis of Illegal Added Phenformin Hydrochloride in Chinese Patent Medicines¡¡/ 147

NIR Analysis of Liquid Formulations ¡¡/ 152

CASE STUDY 17¡¡ Construction NIR Quantitative Model for Glucose Injection ¡¡/ 154

Applications of NIR Methods on Mobile Laboratory Vehicles ¡¡/ 161

CASE STUDY 18¡¡ The Establishment and Application of Blank Models Used for Spectra Comparison ¡¡/ 164

CASE STUDY 19¡¡ Establishment and Application of the Characteristic Spectral Range Screening Method ¡¡/ 171



Chapter 4¡¡Prospect of NIR Analysis Methods¡¡/ 184

Development Prospect of NIR Analytical Instruments ¡¡/ 185

Prospect of the Application of NIR Analysis Method ¡¡/ 186

Prospect of NIR Analysis Methods being Listed in the National Drug Standards of Different Countries¡¡/ 190

References¡¡/ 192



Rapid HPLC Forensic Analysis of Chemical Medicines



Chapter 5¡¡ Basic Principles and Methods for Rapid HPLC Analysis¡¡/ 202

Identification ¡¡/ 202

Content Determination¡¡/ 202

Establishment and Validation of the Rapid HPLC Forensic Method¡¡/ 203



Chapter 6¡¡Applications of Rapid HPLC Analysis¡¡/ 220

β-lactam Antibiotics¡¡/ 221

Macrolide Antibiotics¡¡/ 257

Quinolone Antibiotics ¡¡/ 276

Adrenocortical Hormone Drugs¡¡/ 290

Sex Hormone Drugs¡¡/ 306

Antidiabetic Drugs¡¡/ 318

Calcium Channel Blockers¡¡/ 332



Chapter 7¡¡Progress of Rapid HPLC Analysis¡¡/ 347

Establishment of Reference Database and Applications¡¡/ 347

Rapid Analysis by LC-MS¡¡/ 349



References¡¡/ 353