Quantitative and Qualitative Determination Technologies of Counterfeit Drugs

Cover
Half Title
Series Information
Title Page
Copyright Page
Table of Contents
Preface
Editor
List of Contributors
1 Screening for Bad-Quality Pharmaceuticals in Field Settings
1.1 Introduction
1.1.1 Scope and Scale of the Problem
1.1.2 Who Defines Quality?
1.1.3 What Do Regulators in LMICs Do to Help Catch SFPs?
1.1.4 What Is Field Screening?
1.1.5 How Does Field Screening Help Solve the Problem of SFPs?
1.2 What Can Go Wrong With Pharmaceuticals?
1.2.1 Pharmaceuticals Can Be Badly Made
1.2.2 Pharmaceuticals Can Be Badly Packaged Or Transported and Stored in Ways That Cause Degradation of Quality
1.2.3 Pharmaceuticals Can Be Dispensed Badly
1.2.4 The Manufacturer Can Be Unresponsive
1.3 Instrument-Free Field Screening Technologies
1.3.1 What Analytical Metrics Are Appropriate for Field Screening Technologies?
1.3.2 Packaging Inspection
1.3.3 Glassware-Based Field Color Tests
1.3.4 Thin-Layer Chromatography
1.3.5 Merck-GPHF MinilabTM
1.3.6 Disintegration/Dissolution Testing
1.3.7 Lateral Flow Immunoassay Strips
1.3.8 Paper Microfluidics: the Paper Analytical Device (PAD)
1.3.8.1 How the PAD Works
1.3.8.2 Test Development
1.3.8.3 Making PADs
1.3.8.4 Data Analytics for the PAD
1.4 An Implementation Case Study: Paper Analytical Device (PAD)
1.5 Who Tests the Tests?
1.5.1 LOMWRU Multiphase Review
1.5.2 USP Technology Review Program
1.6 Conclusion
References
2 HPLC for Analysis of Substandard and Falsified Medicinal Products
2.1 Introduction
2.2 Falsified Medicines
2.2.1 Illegal Preparations Containing Small Molecules
2.2.1.1 Characterization of Suspected APIs
2.2.1.2 Characterization of Suspected Finished Products
2.2.2 Illegal Preparations Containing Macromolecules
2.2.2.1 Protein Or Peptide
2.2.2.2 Use of LC-MS for the Identification of Illegal Peptide Drugs
2.2.2.3 Use of LC-MS in the Identification of Illegal Protein Drugs
2.2.2.4 Quantification of Polypeptide Drugs By Means of Chromatography
2.3 Regulated and Toxic Plants in Traditional Medicinal Products and Plant Food Supplements
2.4 Conclusion
References
3 Tackling a Global Crisis: A Review of the Efficacy of LC-MS
3.1 Introduction
3.2 Chromatography Coupled With Mass Spectrometry
3.3 Counterfeit Drugs for Pathogenic Diseases
3.4 Counterfeit Drugs for Erectile Dysfunction
3.5 Counterfeit Drugs for Steroids
3.6 Counterfeit Drugs for Obesity
3.7 Concerning Counterfeit Drugs With Detrimental Effects
3.8 Conclusion
References
4 Analyzing Counterfeit and Falsified Herbal Products With GC/MS
4.1 Introduction
4.2 Adulteration of Herbal Drugs
4.2.1 Reasons for Adulteration
4.2.2 Various Methods of Adulteration of Herbal Drugs
4.3 Types of Analysis for Authentication Identification
4.3.1 Detection of Active Pharmaceutical Ingredients in Counterfeit Herbal Drugs
4.3.2 Sample Preparation Prior to Analytical Toxicology Process
4.3.2.1 Microextraction Techniques
4.3.2.2 Liquid Phase Extraction (LPE)
4.3.2.3 Pressurized Liquid Extraction (PLE)
4.3.2.4 Dispersive Liquid-Liquid Microextraction (DLLME)
4.3.2.5 Ultrasonic Assisted Extraction
4.3.2.6 Microwave Assisted Extraction (MAE)
4.3.2.7 Dispersive Liquid-Liquid Microextraction (DLLME)
4.3.2.8 Hollow Fiber-Based Liquid-Phase Microextraction
4.3.2.9 Solid Phase Extraction (SPE)
4.3.2.10 Solid Phase Microextraction (SPME)
4.3.2.11 Dispersive Solid-Phase Extraction (d-SPE)
4.3.2.12 QuEChERS
4.3.3 Instrumental Methods for Undeclared Drug Detection in Counterfeit Herbal Drugs
4.3.3.1 Spectrophotometric Techniques
4.3.3.2 Chromatographic Techniques
4.3.3.2.4 Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
4.4 Gas Chromatography/Mass Spectrometry for Counterfeit Herbal Drugs Detection
4.5 Comparing GC/MS and HPLC in the Analysis of Counterfeit Herbal Drugs
4.6 Necessity for Method Validation in Counterfeit Drug Analysis
4.6.1 Method Validation
4.6.1.1 Selectivity
4.6.1.2 Accuracy
4.6.1.3 Precision
4.6.1.4 Limit of Detection (LOD)
4.6.1.5 Limit of Quantification (LOQ)
4.6.1.6 Linearity
4.6.1.7 Recovery of Extraction Efficiency
4.7 Conclusion
References
5 Applications of UV-Vis Spectroscopy in Counterfeit Medications
5.1 Introduction
5.2 Ultraviolet Visible Spectroscopy
5.3 Quantitative UV-Vis
5.4 Qualitative UV-Vis
5.5 Conclusion
References
6 IR Spectroscopic Analytical Tools in the Fight Against Counterfeit Medicines
6.1 Introduction
6.2 Fundamentals of Infrared Spectroscopy
6.2.1 Near-Infrared Spectroscopy
6.2.2 Mid-Infrared Spectroscopy
6.2.2.1 Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy
6.2.3 Comparison of NIR and ATR-FTIR Spectroscopy
6.3 Chemometric Approaches Used in Combination With IR Spectroscopy
6.3.1 Data Pre-Processing
6.3.2 Unsupervised Methods
6.3.2.1 Principal Component Analysis
6.3.3 Supervised Methods
6.3.3.1 Linear Discriminant Analysis
6.3.3.2 Soft Independent Modelling of Class Analogies
6.3.3.3 Data Driven-Soft Independent Modelling of Class Analogies
6.3.3.4 Partial Least Squares-Discriminant Analysis
6.3.3.5 K-Nearest Neighbour
6.3.3.6 Classification and Regression Tree
6.3.4 Regression Methods
6.3.4.1 Principal Component Regression
6.3.4.2 Partial Least Squares Regression
6.4 Applications of IR Techniques for the Detection of Counterfeit and Substandard Medicines
6.4.1 Near-Infrared Spectroscopy Applications
6.4.2 Mid-Infrared Spectroscopy Applications
6.5 Conclusion
6.6 In Memoriam: Dr Graham Lawson
6.7 Acknowledgments
References
7 Using NMR Spectroscopy to Analyze Counterfeit Medications
7.1 Introduction
7.2 Nuclear Magnetic Resonance (NMR)
7.3 Quantitative NMR
7.4 Qualitative NMR
7.5 Conclusion
References
Index