HPLC Method Development and Validation in Pharmaceutical Analysis

Written By Ghulam Shabir
HPLC Method Development and Validation in Pharmaceutical Analysis
  • Publsiher : LAP Lambert Academic Publishing
  • Release : 01 January 2013
  • ISBN : 9783659321207
  • Pages : 492 pages
  • Rating : /5 from reviews
GET THIS BOOKHPLC Method Development and Validation in Pharmaceutical Analysis


Download or read book entitled HPLC Method Development and Validation in Pharmaceutical Analysis by author: Ghulam Shabir which was release on 01 January 2013 and published by LAP Lambert Academic Publishing with total page 492 pages . This book available in PDF, EPUB and Kindle Format. 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.

HPLC Method Development for Pharmaceuticals

HPLC Method Development for Pharmaceuticals
  • Author : Satinder Ahuja,Henrik Rasmussen
  • Publisher : Elsevier
  • Release Date : 2011-09-21
  • Total pages : 532
  • ISBN : 9783659321207
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Summary : 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 ...

HPLC Method Development and Validation in Pharmaceutical Analysis

HPLC Method Development and Validation in Pharmaceutical Analysis
  • Author : Ghulam Shabir
  • Publisher : LAP Lambert Academic Publishing
  • Release Date : 2013-01
  • Total pages : 492
  • ISBN : 9783659321207
GET BOOK

Summary : 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 ...

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,Phil W. Nethercote
  • Publisher : John Wiley & Sons
  • Release Date : 2014-10-27
  • Total pages : 440
  • ISBN : 9783659321207
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Summary : This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included ...

Analytical Method Development and Validation

Analytical Method Development and Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher : CRC Press
  • Release Date : 2018-10-03
  • Total pages : 96
  • ISBN : 9783659321207
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Summary : 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 ...

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
  • Author : Satish Y. Gabhe
  • Publisher : diplom.de
  • Release Date : 2015-08-01
  • Total pages : 108
  • ISBN : 9783659321207
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Summary : 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 ...

Validation of Analytical Methods for Pharmaceutical Analysis

Validation of Analytical Methods for Pharmaceutical Analysis
  • Author : Oona McPolin
  • Publisher : Lulu.com
  • Release Date : 2009-05-01
  • Total pages : 152
  • ISBN : 9783659321207
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Summary : 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 ...

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC
  • Author : Satinder Ahuja,Michael Dong
  • Publisher : Elsevier
  • Release Date : 2005-02-09
  • Total pages : 600
  • ISBN : 9783659321207
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Summary : 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 ...

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods
  • Author : Christopher M. Riley,Thomas W. Rosanske
  • Publisher : Elsevier
  • Release Date : 1996-05-29
  • Total pages : 349
  • ISBN : 9783659321207
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Summary : The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted ...

Practical Hplc and Lc Ms Method Development and Validation

Practical Hplc and Lc Ms Method Development and Validation
  • Author : Ghulam A. Shabir
  • Publisher : LAP Lambert Academic Publishing
  • Release Date : 2012-06
  • Total pages : 308
  • ISBN : 9783659321207
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Summary : 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 ...

Development of Novel Stability Indicating Methods Using Liquid Chromatography

Development of Novel Stability Indicating Methods Using Liquid Chromatography
  • Author : Mukesh Maithani,Parveen Bansal
  • Publisher : Springer
  • Release Date : 2019-08-07
  • Total pages : 101
  • ISBN : 9783659321207
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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 ...

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-14
  • Total pages : 256
  • ISBN : 9783659321207
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Summary : A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits ...

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification
  • Author : Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
  • Publisher : John Wiley & Sons
  • Release Date : 2004-04-23
  • Total pages : 320
  • ISBN : 9783659321207
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Summary : Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those ...

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release Date : 2021-01-09
  • Total pages : 222
  • ISBN : 9783659321207
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Summary : Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed ...

Handbook of Analytical Validation

Handbook of Analytical Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher : CRC Press
  • Release Date : 2012-04-24
  • Total pages : 220
  • ISBN : 9783659321207
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Summary : 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 ...

Capillary Electrophoresis Methods for Pharmaceutical Analysis

Capillary Electrophoresis Methods for Pharmaceutical Analysis
  • Author : Satinder Ahuja,Mohamedilias Jimidar
  • Publisher : Elsevier
  • Release Date : 2011-08-09
  • Total pages : 546
  • ISBN : 9783659321207
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Summary : 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 ...