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