BookMukesh Maithani, Parveen Bansal.
Summary: Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a 'how-to guide to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.
Contents:
Intro; Preface; Acknowledgements; Overview; Contents; About the Authors; Abbreviations;
1: Introduction; 1.1 Introduction to Analytical Methods; 1.2 History of Chromatography; 1.3 High-Performance Liquid Chromatography; 1.3.1 High-Performance Adsorption Chromatography; 1.3.2 High-Performance Partition Chromatography; 1.3.3 High-Performance Ion-Exchange Chromatography; 1.3.4 High-Performance Size-Exclusion Chromatography; 1.4 Instrumentation of High-Performance Liquid Chromatography [9-13]; 1.4.1 Mobile Phase Reservoir; 1.4.2 Pumping System; 1.4.3 Sample Injection System 1.4.4 Stationary Phase (Column)1.4.5 Detector; 1.4.6 Data System; 1.4.7 Backpressure Regulator; 1.5 Applications of HPLC; 1.6 General Considerations for HPLC Method Development; 1.6.1 Various Steps for Method Development [15, 16]; 1.6.2 Optimization of the Method Development Parameters [17, 18]; 1.7 HPLC Method Validation [19-23]; 1.7.1 Validation Parameters; 1.7.1.1 Different Validation Parameters; 1.7.1.2 Statistical Validation [24, 25]; 1.8 System Suitability [26, 27]; 1.8.1 Capacity Factor; 1.8.2 Efficiency; 1.8.3 Selectivity; 1.8.4 Resolution; 1.8.5 Tailing Factor 1.8.6 Asymmetry Factor1.9 Stability-Indicating Method Development [28-30]; 1.9.1 Objective of Stability Studies; 1.9.2 Stability Protocols [31]; 1.9.3 Degradation Pathways and Their Role in SIM Development; 1.9.3.1 Need of Stress Testing in SIMs; References;
2: Research Envisaged; 2.1 Plan of Work;
3: Drug(s) Profile; 3.1 Ambroxol Hydrochloride; 3.1.1 Description [1-3]; 3.1.2 Pharmacopoeial Specifications; 3.1.3 Pharmacology [7-10]; 3.1.4 Adverse Effect; 3.1.5 Drug Interaction; 3.1.6 Doses; 3.1.7 Brand Name; 3.2 Cetirizine Hydrochloride; 3.2.1 Description [1-3] 3.2.2 Pharmacopoeial Specifications3.2.3 Pharmacology; 3.2.4 Interaction Studies; 3.2.5 Toxicity; 3.2.6 Side Effects; 3.2.7 Adverse Effects; 3.2.8 Dosage and Safety [17, 18]; 3.2.9 Brand Names; 3.3 Chlorpheniramine Maleate; 3.3.1 Description [2, 3]; 3.3.2 Pharmacopoeial Specifications [4-6]; 3.3.3 Pharmacological Action; 3.3.4 Indications and Usage; 3.3.5 Adverse Effects; 3.3.6 Drug Interactions; 3.3.7 Doses [14, 15]; 3.3.8 Dosage Forms [16]; 3.3.9 Brand Names; 3.4 Guaiphenesin; 3.4.1 Descriptions [1-3]; 3.4.2 Pharmacopoeial Specifications [4-6]; 3.4.3 Pharmacology 3.4.4 Adverse Effect3.4.5 Drug Interaction; 3.4.6 Dose; 3.4.7 Brand Names; 3.5 Paracetamol; 3.5.1 Description; 3.5.2 Pharmacopoeial Specifications [4-6]; 3.5.3 Pharmacological Action; 3.5.4 Indications and Usage; 3.5.5 Adverse Effects; 3.5.6 Drug Interactions; 3.5.7 Doses; 3.5.8 Dosage Forms; 3.5.9 Brand Names; 3.6 Phenylephrine Hydrochloride; 3.6.1 Description [1-3]; 3.6.2 Pharmacopoeial Specifications [4-6]; 3.6.3 Pharmacological Action; 3.6.4 Indications and Usage; 3.6.5 Adverse Effects; 3.6.6 Contraindications; 3.6.7 Overdose; 3.6.8 Drug Interactions