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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

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.

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

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.

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.

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.

Development of Novel Stability Indicating Methods Using Liquid Chromatography

Development of Novel Stability Indicating Methods Using Liquid Chromatography Book
Author : Mukesh Maithani,Parveen Bansal
Publisher : Springer
Release : 2019-08-07
ISBN : 9811387230
Language : En, Es, Fr & De

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Book Description :

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.

Software Assisted Method Development in High Performance Liquid Chromatography

Software Assisted Method Development in High Performance Liquid Chromatography Book
Author : Szabolcs Fekete,Imre Molnár
Publisher : World Scientific
Release : 2019-01-01
ISBN : 1786345471
Language : En, Es, Fr & De

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Book Description :

This handbook gives a general overview of the possibilities in recent developments in chromatographic retention modeling. As a result of the latest developments in modeling software, several new features are now accessible, opening a new level in HPLC method development. Many of these current possibilities in software assisted liquid chromatographic method modeling for analytical purposes are presented. Several modes of chromatography, including Reversed-Phase Liquid Chromatography (RPLC), Ion Exchange Chromatography (IEX), Hydrophobic Interaction Chromatography (HIC), and Hydrophilic Interaction Liquid Chromatography (HILIC) are explained in detail. For all these chromatographic modes, the most important variables for tuning retention and selectivity are exposed. Beside the industrial and practical benefits of retention modeling, the possibilities in teaching and education are also illustrated. Finally, numerous representative industrial examples are shown, to highlight the benefits, time and cost savings offered by state-of-the-art software assisted HPLC method development.

Practical Hplc and Lc Ms Method Development and Validation

Practical Hplc and Lc Ms Method Development and Validation Book
Author : Ghulam A. Shabir
Publisher : LAP Lambert Academic Publishing
Release : 2012-06
ISBN : 9783659123528
Language : En, Es, Fr & De

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Book Description :

The coherent body of research described in this book is concerned with new HPLC method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical 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 and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important 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 and LC-MS. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis Book
Author : Satinder Ahuja,Stephen Scypinski
Publisher : Academic Press
Release : 2010-11-11
ISBN : 9780123759818
Language : En, Es, Fr & De

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Book Description :

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

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 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

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets Book
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Release : 2009-12-04
ISBN : 9781441908896
Language : En, Es, Fr & De

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Book Description :

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis Book
Author : Joachim Ermer,John H. McB. Miller
Publisher : John Wiley & Sons
Release : 2006-03-06
ISBN : 3527604472
Language : En, Es, Fr & De

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Book Description :

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

High Performance Liquid Chromatography

High Performance Liquid Chromatography Book
Author : W.J. Lough,I.W. Wainer
Publisher : CRC Press
Release : 1995-09-30
ISBN : 9780751400762
Language : En, Es, Fr & De

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Book Description :

High performance liquid chromatography (HPLC) has long been recognized as one of the most useful and versatile analytical techniques. It has now progressed from being a highly expensive method of analysis to a routine technique with wide applications. Consequently there is a requirement in many chemistry and chemistry-related courses for students to acquire a detailed understanding of the principles and practice of HPLC. Written in a manner suitable for undergraduate students studying analytical chemistry and learning about chromatographic analytical techniques applied to pharmaceutical analysis, biochemistry and related disciplines, High-performance Liquid Chromatography: Fundamental Principles and Practice introduces the fundamentals of HPLC. Loosely structured in three parts, the text begins with a thorough introduction of the subject and then progresses through the essential knowledge of the instrumentation needed for HPLC. The final part covers with the applications of HPLC in real-world situations. Developed by a team of international experts from a wide cross-section of disciplines, the text is relevant to a wide range of courses.