Pharmaceutical Drug Analysis.
Title:
Pharmaceutical Drug Analysis.
Author:
Kar, Ashutosh.
ISBN:
9788122427189
Personal Author:
Edition:
2nd ed.
Physical Description:
1 online resource (554 pages)
Contents:
Cover -- Preface to the Second Edition -- Preface to the First Edition -- Contents -- Part-l General Aspects -- Chapter 1. Pharmaceutical Chemicals: Purity and Management -- 1.1 Introduction -- 1.2 Purity -- 1.2.1 Broad-Based Highest Attainable Standard -- 1.2.2 Biological Response Vs.Chemical Purity -- 1.2.3 Official Standards vis-a-vis Manufacturing Standards -- 1.3 Management -- 1.3.1 Description of the Drug or Finished Product -- 1.3.2 Sampling Procedures and Errors -- 1.3.3 Bioavailability -- 1.3.4 Identification Tests -- 1.3.5 Physical Constants -- 1.3.6 Limit Tests vis-a-vis Quantitative Determinations -- 1.3.7 Various Types of Tests for Quantitative Determinations -- 1.3.8 Limit Tests for Metallic Impurities -- 1.3.9 Limit Test's for Acid Radical Impurities -- 1.3.10 Limit Tests for Non-Metallic Impurities -- Chapter 2. Theory and Technique of Quantitative Analysis -- 2.1 Introduction -- 2.2 Volumetric Analysis -- 2.2.1 Theory -- 2.2.2 Definitions -- 2.2.3 Volumetric Apparatus -- 2.2.4 General Considerations -- 2.2.5 Technique of Volumetric Analysis -- 2.3 Gravimetric Analysis -- 2.4 Biomedical Analytical Chemistry -- 2.4.1 Colorimetric Assays -- 2.4.2 Enzymatic Assays -- 2.4.3 Radioimmuno Assays (RIAS) -- 2.4.4 Automated Methods of Clinical Analysis -- Chapter 3. Errors in Pharmaceutical Analysis and Statistical Validation -- 3A. Errors in Pharmaceutical Analysis -- 3A.1. Introduction -- 3A.2. Classification of Errors -- 3A.2.1. Determinate (Systematic) Errors -- 3A.2.2. Indeterminate (Random) Errors -- 3A.2.3 Accuracy -- 3A.2.4. Precision -- 3A.2.5 Minimising Systematic Errors -- 3B. Statistical Validation -- 3B.1 Introduction -- 3B.2 Statistical Validation -- 3B.2.1 Statistical Treatement of Finite Samples -- 3B.2.2. Distribution of Random Numbers -- 3B.2.3 Significant Figures -- 3B.2.4 Comparison of Results.
3B.2.5 Method of Least Squares -- 3B.2.6 Recommendations for Criteria of Rejecting an Observation -- 3B.2.7 Sampling Statistics -- Part ll Chemical Methods -- A. Titrimetric Methods: Acidimetry and Alkalimetry -- Chapter 4. Aqueous Titrations -- 4.1 Introduction -- 4.1.1 Lowry and Bronsted's Theory of Acid and Bases -- 4.1.2. Lewis's Theory -- 4.1.3 Usanovich Theory -- 4.1.4 Lux-Flood Concept -- 4.2 Theory of Acidimetry -- 4.2.1 Direct Titration Method -- 4.2.2 Residual Titration Method -- 4.3 Assay of Drugs -- 4.3.1 Direct Titration Method -- 4.3.2 Residual Titration Method -- 4.4 Theory of Alkalimetry -- 4.4.1 Direct Titration Method (DTM) -- 4.4.2 Residual Titration Methods (RTM) -- Chapter 5. Non-Aqueous Titrations -- 5.1 Introduction -- 5.2 Theory -- 5.2.1 Solvents -- 5.3 Methodology -- 5.3.1 Preparation of 0.1 N Perchloric Acid -- 5.3.2 Standardization of 0.1 N Perchloric Acid -- 5.3.3 Choice of Indicators -- 5.3.4 Effects of Temperature on Assays -- 5.4 Assay by Non-Aqueous Titrations -- 5.4.1 Acidimetry in Non-Aqueous Titrations -- 5.4.2 Alkalimetry in Non-Aqueous Titrations -- B. Redox Methods -- Chapter 6. Permanganate Dichromate and Ceric Sulphate Titration Methods -- 6.1 Introduction -- 6.2 Theory -- 6.3 Assay Methods -- 6.3.1 Permanganate Methods -- 6.3.2 Dichromate Methods -- 6.3.3 Ceric Sulphate Titration Methods -- Chapter 7. Iodimetric and Iodometric Titrations -- 7.1 Introduction -- 7.2 Theory -- 7.3 Assay Methods -- 7.3.1 Iodimetric Assays -- 7.3.2 Iodometric Assays -- C. Precipitation Methods -- Chapter 8. Argentometric Methods -- 8.1 Introduction -- 8.2 Theory -- 8.3 Assay Methods -- 8.3.1 Direct Titration with Silver Nitrate -- 8.3.2 Ammonium Thiocyanate-Silver Nitrate Titrations (Volhard's Method) -- D.Complexometric Methods -- Chapter 9. Complexometric Analysis -- 9.1 Introduction -- 9.2 Theory.
9.2.1 Effect of pH on Complexation -- 9.2.2 Stability of Complexes -- 9.2.3 Colouration of Complexes -- 9.2.4 Titrability of Polyvalent Metal Ions Employing Disodium Edetate -- 9.2.5 Usage of pM Indicators in Complexometric Titrations -- 9.3 Assay Methods -- 9.3.1 Direct Titration Methods -- 9.3.2 Masking and Demasking Agents -- 9.3.3 Residual Titration Methods -- E. Gravimetric Methods -- Chapter 10. Gravimetric Analysis -- 10.1 Introduction -- 10.2 Theory -- 10.2.1 Law of Mass Action and Reversible Reactions -- 10.2.2 Principle of Solubility of Product -- 10.2.3 Comnion Ion Effect -- 10.3 Assay Methods -- 10.3.1 Substances Assayed Gravimetrically -- 10.3.2 Substances Assayed After Conversion -- F. Thermoanalytical Methods -- Chapter 11. Thermoanalytical Analysis -- 11.1 Introduction -- 11.2 Thermogravimetric Analysis (TGA) -- 11.2.1 Theory -- 11.2.2 Instrumentation -- 11.2.3 Methodology -- 11.3 Differential Thermal Analysis (DTA) -- 11.3.1 Theory -- 11.3.2 Instrumentation -- 11.3.3 Methodology -- 11.3.4 Applications -- 11.4 Thermometric Titrations (TT) -- 11.4.1 Theory -- 11.4.2 Instrumentation -- 11.4.3 Methodology -- 11.4.4 Applications -- G. Miscellaneous Methods -- Chapter 12. Diazotization (Sodium Nitrite Titration) -- 12.1 Introduction -- 12.2 Theory -- 12.3 Assay Methods -- 12.3.1 Preparation of 0.1 M Sodium Nitrite Solution -- 12.3.2 Standardization of 0.1 M Sodium Nitrite Solution with Sulphanilamide -- 12.3.3 Calcium Aminosalicylate -- 12.3.4 Isocarboxazid -- 12.3.5 Phthalylsulphathiazole -- 12.3.6 Cognate Assays -- Chapter 13. Estimation of Phenols and Related Compounds -- 13.1 Introduction -- 13.2 Theory -- 13.3 Assay Methods -- 13.3.1 Titrations with 0.1 N Bromine -- 13.3.2 Titrations with Potassium Bromate -- 13.3.3 Titrations with Potassium Iodate -- Chapter 14. Karl Fischer Method for Determination of Water -- 14.1 Introduction.
14.2 Theory -- 14.3 Instrumentation -- 14.3.1 Automated Electrochemical Karl Fischer Analysis -- 14.4 Applications of Karl Fischer Method for Determination of Water in Pharmaceutical Analysis -- 14.4.1 Prednisolone Sodium Phosphate -- 14.4.2 Cognate Assays -- Chapter 15. Tetrazolium Assay of Steroids -- 15.1 Introduction -- 15.2 Theory -- 15.3 Assay of Pharmaceutical Substances -- 15.3.1 Hydrocortisone Acetate -- 15.3.2 Cognate Assays -- Part lll Electrochemical Methods -- Chapter 16. Potentiometric Methods -- 16.1 Introduction -- 16.2 Theory -- 16.2.1 General Considerations -- 16.2.2 End-Point Determination -- 16.3. Instrumentation -- 16.3.1 Electrodes -- 16.3.2 Automatic Titrator (Preset End-Point Titrator) -- 16.4 Applications of Potentiometric Titrations in Pharmaceutical Analysis -- 16.4.1 Cognate Assays -- Chapter 17. Amperometric Methods -- 17.1 Introduction -- 17.2 Theory -- 17.2.1 Titration Curves -- 17.2.2 Corrections for the Volume Change -- 17.2.3 Advantages of Amperometric Titrations -- 17.3 Instrumentation -- 17.3.1 Amperometric Titrations with the Dropping Mercury Electrode -- 17.3.2 Amperometric Titrations with a Rotating Platinum Microelectrode -- 17.3.3 Amperometric Titrations with Twin-Polarized Microelectrodes(Biamperometric Titrations or Dead-Stop-End-Point Method) -- 17.4 Applications of Amperometric Titrations in Pharmaceutical Substances -- 17.4.1 Procainamide Hydrochloride -- 17.4.2 Cognate Assay -- 17.4.3 Assay of Nickel with Dimethylglyoxime -- 17.4.4 Assay of Lead with Potassium Dichromate Solution -- Part lV Optical Methods -- Chapter 18. Refractometry -- 18.1 Introduction -- 18.2 Theory -- 18.3 Instrumentation -- 18.4 Determination of Refractive Index of Pharmaceutical Substances -- 18.5 Applications of Refractivity -- Chapter 19. Polarimetry -- 19.1 Introduction -- 19.2 Theory -- 19.3 Instrumentation.
19.4 Determination of Optical Activity of Pharmaceutical Substances -- 19.4.1 Determination of Optical Rotation of Pharmaceutical Substances -- 19.4.2 Determination of Specific Optical Rotation of Pharmaceutical Substances -- Chapter 20. Nephelometry and Turbidimetry -- 20.1 Introduction -- 20.2 Theory -- 20.3 Instruments for Nephelometry and Turbidimetry -- 20.3.1 Instruments for Nephelometry -- 20.3.2 Instruments for Turbidimetry -- 20.4 Assay of Pharmaceutical Substances -- 20.4.1 Turbidimetric Assay -- 20.4.2 Nephelometric Assay -- Chapter 21. Ultraviolet and Absorption Methods -- 21.1 Introduction -- 21.2 Theory -- 21.2.1 Electromagnetic Spectrum -- 21.2.2 Schematic Representation of Electromagnetic Spectrum -- 21.2.3 Molar Absorptivity -- 21.2.4 Laws of Photometry -- 21.2.5 Spectral Presentation -- 21.2.6 Structural Features -- 21.2.7 Absorption of Radiant Energy by Molecules -- 21.2.8 Factors Influencing Absorption of Radiant Energy -- 21.3 Instrumentation -- 21.3.1 Single Beam Spectrophometer -- 21.3.2 Double Beam Spectrophometer -- 21.4 Assay Methods -- 21.4.1 Methodology -- 21.4.2 Spectrophotometers -- 21.4.3 Preparation of Sample -- 21.4.4 Measurement of Extinction (E) -- 21.4.5 Examples -- 21.4.6 UV-Absorption Characteristics of Some Official Pharmaceutical Substances -- Chapter 22. Infrared Spectrophotometry -- 22.1 Introduction -- 22.1.1 Group Frequency Region -- 22.1.2 Fingerprint Region -- 22.2 Theory -- 22.2.1 Molecular Vibrations -- 22.2.2 Factors Influencing Vibrational Frequencies -- 22.3 Instrumentation -- 22.3.1 Single Monochromator Infrared Spectrophotometers -- 22.3.2 Double Monochromator Infrared Spectrophotometer -- 22.4 Applications of IR-Spectroscopy in Pharmaceutical Assays -- 22.4.1 Applications of IR-Spectroscopy in the Analysis of Pharmaceutical Substances.
22.4.2 Applications of IR-Spectroscopy in the Analysis of Pharmaceutical Dosage Forms.
Abstract:
About the Book: During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows-based computer software stretched overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of Laboratory Information Management Systems (LIMS) are surprisingly noteworthy. Pharmaceutical Drug Analysis in its present form essentially comprises six parts containing in all 32 well-elaborated chapters predominantly dealing with the set of descriptive analytical methodologies developed to control and assure the quality of the final marketed product; and, therefore, includes both qualitative and quantitative methods of analysis to help in the identification as well as purity of the product. The main purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each technique is critically treated with emphasis on factors that directly affect its proper and judicious application to various analytical problems. An in-depth knowledge of these principles, instrumentations, modus operandi, experimental parameters, and sample preparation procedures in order to optimize the performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms, calculations etc., along with cognate assays from the Official Compendia have been included profusely. Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists, industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial fundamental understanding and knowledge
of the subject will certainly find this a much needed suitable compilation for reading and reference. The broad coverage included in each of the selected analytical techniques would render Pharmaceutical Drug Analysis to be an useful source of ideas, inspiration for research, and developing newer practical solutions to problems in the ever expanding field of pharmaceutical analysis. Contents: Part I: GENERAL ASPECTS Pharmaceutical Chemicals: Purity and Management Theory and Technique of Quantitative Analysis Errors in Pharmaceutical Analysis and Statistical Validation Part II: CHEMICAL METHODS Titrimetric Methods: Acidimetry and Alkalimetry¾Aqueous Titrations, Non-Aqueous Titration Redox Methods¾Permanganate, Dichromate and Ceric Sulphate Titration Methods, Iodimetric and Iodometric Titrations Precipitation Methods-Argentometric Methods Complexometric Methods-Complexometric Analysis Gravimetric Methods-Gravimetric Analysis Thermoanalytical Methods-Thermoanalytical Analysis Miscellaneous Methods-Diazotization Estimation of Phenols and Related Compounds Karl Fisher Method for Determination of Water Tertazolium Assay of Steroids Part III: ELECTROCHEMICAL METHODS Potentiometric Methods Amperometric Methods Part IV: OPTICAL METHODS Refractometry Polarimetry Nephelometry and Turbidimetry Ultraviolet and Absorption Methods Infrared Spectrophotometry Nuclear Magnetic Resonance Spectroscopy Emission Spectroscopy Flame Spectroscopy Atomic Absorption Spectroscopy Part V: ASSAY METHODS BASED ON SEPARATION TECHNIQUES Liquid-Liquid Extraction Thin Layer Chromatography (TLC) Gas-Liquid Chromatography (GLC) High Performance Liquid Chromatography (HPLC) Size Exclusion Chromatography Part VI: MISCELLANEOUS METHODS Radioimmunoassay.
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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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