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HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals Book
Author : Satinder Ahuja,Henrik Rasmussen
Publisher : Elsevier
Release : 2011-09-21
ISBN : 0080554199
Language : En, Es, Fr & De

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Book Description :

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Analytical Method Development and Validation

Analytical Method Development and Validation Book
Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Release : 2018-10-03
ISBN : 1482229773
Language : En, Es, Fr & De

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Book Description :

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists Book
Author : Yuri V. Kazakevich,Rosario LoBrutto
Publisher : John Wiley & Sons
Release : 2007-02-16
ISBN : 0470087943
Language : En, Es, Fr & De

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Book Description :

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC Book
Author : Satinder Ahuja,Michael Dong
Publisher : Elsevier
Release : 2005-02-09
ISBN : 9780080455181
Language : En, Es, Fr & De

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Book Description :

High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations HPLC And HPTLC Techniques

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations  HPLC And HPTLC Techniques Book
Author : Satish Y. Gabhe
Publisher : diplom.de
Release : 2015-08-01
ISBN : 3954898071
Language : En, Es, Fr & De

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Book Description :

This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

An Introduction to HPLC for Pharmaceutical Analysis

An Introduction to HPLC for Pharmaceutical Analysis Book
Author : Oona McPolin
Publisher : Lulu.com
Release : 2009-03-01
ISBN : 0956152805
Language : En, Es, Fr & De

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Book Description :

If you are new to HPLC, this book provides an invaluable guide to how HPLC is actually used when analysing pharmaceuticals. It is full of practical advice on the operation of HPLC systems combined with the necessary theoretical knowledge to ensure understanding of the technique. Key features include: A thorough discussion of the stationary phase enabling the reader to make sense of the many parameters used to describe a HPLC column; Practical advice and helpful hints for the preparation and use of mobile phase; A complete overview of each of the different components which together make up a HPLC system; A description of the contents of a typical HPLC analytical method and how to interpret these; A step-by-step guide on how to follow a method and set up a HPLC analysis; A discussion of system suitability criteria and how to interpret the values obtained during an analysis; Explanation of the common methods of calibration and quantification used for pharmaceutical analysis.

HPLC Method Development and Validation in Pharmaceutical Analysis

HPLC Method Development and Validation in Pharmaceutical Analysis Book
Author : Ghulam Shabir
Publisher : LAP Lambert Academic Publishing
Release : 2013-01
ISBN : 9783659321207
Language : En, Es, Fr & De

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Book Description :

This handbook is concerned with new chromatographic method development and validation using novel systematic approaches for pharmaceutical compounds. The first stage of the research was to study how method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners in the pharmaceutical industry. Furthermore, it was recognised that this protocol should satisfy the requirements of the major regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC, LC-MS and GC. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of single guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis Book
Author : Joachim Ermer,Phil W. Nethercote
Publisher : John Wiley & Sons
Release : 2014-08-27
ISBN : 3527672184
Language : En, Es, Fr & De

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Book Description :

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Specification of Drug Substances and Products

Specification of Drug Substances and Products Book
Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
Publisher : Elsevier
Release : 2020-07-23
ISBN : 0081028253
Language : En, Es, Fr & De

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Book Description :

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Analytical Method Development and Validation of Antiviral Drug

Analytical Method Development and Validation of Antiviral Drug Book
Author : Anas Rasheed,Osman Ahmed
Publisher : LAP Lambert Academic Publishing
Release : 2015-06-30
ISBN : 9783659751400
Language : En, Es, Fr & De

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Book Description :

Giving a brief account of methods of estimation of Drugs, followed by brief account of HPLC method, instrumentation, performance calculations and information related to proposed method. Another part of work is method validation which includes introduction, steps in validation, validation report and validation parameters for chromatographic methods. RP-HPLC method for the quantitative estimation of Antiviral drug. These methods are validated in terms of sensitivity, accuracy and precision and can be used for the routine determination of Antiviral drug, in bulk drug and Pharmaceutical formulations.

HPLC Methods for Recently Approved Pharmaceuticals

HPLC Methods for Recently Approved Pharmaceuticals Book
Author : George Lunn
Publisher : John Wiley & Sons
Release : 2005-05-06
ISBN : 0471711675
Language : En, Es, Fr & De

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Book Description :

An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through thetechnical literature in search of the right HPLC assay techniquesfor your projects. With HPLC Methods for Recently ApprovedPharmaceuticals, you'll quickly identify and replicate the idealprocedures for your project needs, without having to refer tooriginal source publications. More of your time can then be spentin the lab, not the library. Covering the relevant world literature through 2003, this bookpicks up where Dr. Lunn's acclaimed HPLC Methods for PharmaceuticalAnalysis left off. It arms you with established HPLC assaytechniques for hundreds of newly approved drugs, as well as drugsfor which assay methods were only recently developed. Combiningdetailed descriptions of procedures with specially annotatedreferences, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceuticalcompounds * Various procedures for each drug listed together-making it easyto mix and match for customized approaches * Methods for drugs in biological fluids and for bulk andformulated drugs * Chemical structures, molecular weights and formulas, and CASRegistry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the samemethods

Analytical Method Development and Validation of Nicorandil by HPLC

Analytical Method Development and Validation of Nicorandil by HPLC Book
Author : Kanani Nilesh
Publisher : LAP Lambert Academic Publishing
Release : 2015-05-26
ISBN : 9783659429408
Language : En, Es, Fr & De

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Book Description :

Nicorandil is Anti-anginal drug. There are several methods like HPLC, LC-MS, Ultraviolet Spectroscopy etc. are available for the estimation of Nicorandil in biological fluids and pharmaceutical dosage form.we could not trace Single HPLC Method with short Retention Time (RT). So to develop and validate a HPLC method for the estimation of Nicorandil in Pharmaceutical with the retention time around 5 min. HPLC method for estimation of Nicorandil in its dosage form was developed. The developed HPLC method was validated for specificity, linearity and range, accuracy, method and intermediate precision, robustness, system suitability and applied to pharmaceutical formulation and the %Assay of Nicorandil Tablets was found to be in the range of 98-102%. For developing HPLC technique for analysis of Nicorandil tablet. Numbers of trials were taken for selection of column, mobile phase. The developed method was validated as per ICH guideline. The advantages of chromatographic techniques were higher accuracy, small sample size and less consuming, however it requires costly HPLC grade solvents and availability of HPLC instrument. This method can be successfully applied for the estimation.

Development and Validation of HPLC Method for Combined Dosage Form

Development and Validation of HPLC Method for Combined Dosage Form Book
Author : Digbijay Kumar,Disha Sheth
Publisher : LAP Lambert Academic Publishing
Release : 2013
ISBN : 9783659438691
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. This presentation will discuss the development and validation of analytical method Spectrophotometric and High performance liquid chromatography (HPLC), for drug products containing more than one active ingredient. This book deals with various approaches applied for the development and validation of analytical method for paracetamol and pamabrom.

Validation of Analytical Methods for Pharmaceutical Analysis

Validation of Analytical Methods for Pharmaceutical Analysis Book
Author : Oona McPolin
Publisher : Lulu.com
Release : 2009-05-01
ISBN : 0956152813
Language : En, Es, Fr & De

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Book Description :

This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

Modern HPLC for Practicing Scientists

Modern HPLC for Practicing Scientists Book
Author : Michael W. Dong
Publisher : John Wiley & Sons
Release : 2016-04-06
ISBN : 111929360X
Language : En, Es, Fr & De

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Book Description :

A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.

HPLC and UHPLC for Practicing Scientists

HPLC and UHPLC for Practicing Scientists Book
Author : Michael W. Dong
Publisher : John Wiley & Sons
Release : 2019-07-23
ISBN : 1119313767
Language : En, Es, Fr & De

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Book Description :

A concise yet comprehensive reference guide on HPLC/UHPLC that focuses on its fundamentals, latest developments, and best practices in the pharmaceutical and biotechnology industries Written for practitioners by an expert practitioner, this new edition of HPLC and UHPLC for Practicing Scientists adds numerous updates to its coverage of high-performance liquid chromatography, including comprehensive information on UHPLC (ultra-high-pressure liquid chromatography) and the continuing migration of HPLC to UHPLC, the modern standard platform. In addition to introducing readers to HPLC’s fundamentals, applications, and developments, the book describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. HPLC and UHPLC for Practicing Scientists, Second Edition offers three new chapters. One is a standalone chapter on UHPLC, covering concepts, benefits, practices, and potential issues. Another examines liquid chromatography/mass spectrometry (LC/MS). The third reviews at the analysis of recombinant biologics, particularly monoclonal antibodies (mAbs), used as therapeutics. While all chapters are revised in the new edition, five chapters are essentially rewritten (HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects). The book also includes problem and answer sections at the end of each chapter. Overviews fundamentals of HPLC to UHPLC, including theories, columns, and instruments with an abundance of tables, figures, and key references Features brand new chapters on UHPLC, LC/MS, and analysis of recombinant biologics Presents updated information on the best practices in method development, validation, operation, troubleshooting, and maintaining regulatory compliance for both HPLC and UHPLC Contains major revisions to all chapters of the first edition and substantial rewrites of chapters on HPLC columns, instrumentation, pharmaceutical analysis, method development, and regulatory aspects Includes end-of-chapter quizzes as assessment and learning aids Offers a reference guide to graduate students and practicing scientists in pharmaceutical, biotechnology, and other industries Filled with intuitive explanations, case studies, and clear figures, HPLC and UHPLC for Practicing Scientists, Second Edition is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology. It will be a great benefit to every busy laboratory analyst and researcher.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development Book
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Release : 2008-11-16
ISBN : 0387856277
Language : En, Es, Fr & De

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Book Description :

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Handbook of Analytical Validation

Handbook of Analytical Validation Book
Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Release : 2012-04-24
ISBN : 0824706897
Language : En, Es, Fr & De

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Book Description :

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

Capillary Electrophoresis Methods for Pharmaceutical Analysis

Capillary Electrophoresis Methods for Pharmaceutical Analysis Book
Author : Satinder Ahuja,Mohamedilias Jimidar
Publisher : Elsevier
Release : 2011-08-09
ISBN : 0080559611
Language : En, Es, Fr & De

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Book Description :

Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control. - Provides current status and future developments in CE analysis of pharmaceuticals. - Explains how to develop and validate methods. - Includes major pharmaceutical applications including assays and impurity testing.

Supercritical Fluid Chromatography

Supercritical Fluid Chromatography Book
Author : Gregory K. Webster
Publisher : CRC Press
Release : 2014-02-04
ISBN : 9814463000
Language : En, Es, Fr & De

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Book Description :

Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges of today’s pharmaceutical industry. One technique that has made steady advances in pharmaceutical analysis is supercritical fluid chromatography (SFC). SFC is meeting the chromatography needs of the industry by providing efficient and selective testing capabilities on the analytical and preparative scale. The supercritical fluid mobile phase, consisting mainly of CO2, facilitates cost reduction costs and helps the industry in meeting green chemistry standards. This book provides a comprehensive overview of the use of SFC in pharmaceutical analysis. Supercritical Fluid Chromatography reviews the use of SFC in drug-discovery applications and describes its application in drug development. When a drug is developed and brought to market, it is tested many times for impurities and degradants, enantiomeric purity, and analytical and preparative isolations—it is tested during discovery and development and for under-regulated and unregulated methodologies. The book describes the use of SFC for each of these applications and discusses more in-depth topics, such as the use of SFC in mass spectrometric and polarographic detection. The book also sheds light on the role of SFC in drug development from natural products and the advancement of SFC with new technologies and its use in pilot-scale operations as a chromatographic technique.