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Development of Novel Stability Indicating Methods Using Liquid Chromatography

Development of Novel Stability Indicating Methods Using Liquid Chromatography
Author: Mukesh Maithani
Publisher: Springer
Total Pages: 101
Release: 2019-08-07
Genre: Medical
ISBN: 9811387230

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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.


Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Total Pages: 389
Release: 2008-11-16
Genre: Medical
ISBN: 0387856277

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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.


Stability-indicating HPLC Methods for Drug Analysis

Stability-indicating HPLC Methods for Drug Analysis
Author: Quanyun A. Xu
Publisher: Pharmaceutical Press
Total Pages: 936
Release: 2008
Genre: Medical
ISBN:

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Stability-Indicating HPLC Methods for Drug Analysis compiles summaries of stability-indicating HPLC analytical methods that have appeared in the published literature. A first stop for pharmaceutical scientists, analytical chemists, and librarians in the quest for information about the stability of drugs. Co-published by the American Pharmaceutical Association and the Pharmaceutical Press, a division of the Royal Pharmaceutical Society of Great Britain.


HPLC for Pharmaceutical Scientists

HPLC for Pharmaceutical Scientists
Author: Yuri V. Kazakevich
Publisher: John Wiley & Sons
Total Pages: 1136
Release: 2007-02-16
Genre: Science
ISBN: 0470087943

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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.


Selection of the HPLC Method in Chemical Analysis

Selection of the HPLC Method in Chemical Analysis
Author: Serban C. Moldoveanu
Publisher: Elsevier
Total Pages: 600
Release: 2016-11-01
Genre: Science
ISBN: 0128037113

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Selection of the HPLC Method in Chemical Analysis serves as a practical guide to users of high-performance liquid chromatography and provides criteria for method selection, development, and validation. High-performance liquid chromatography (HPLC) is the most common analytical technique currently practiced in chemistry. However, the process of finding the appropriate information for a particular analytical project requires significant effort and pre-existent knowledge in the field. Further, sorting through the wealth of published data and literature takes both time and effort away from the critical aspects of HPLC method selection. For the first time, a systematic approach for sorting through the available information and reviewing critically the up-to-date progress in HPLC for selecting a specific analysis is available in a single book. Selection of the HPLC Method in Chemical Analysis is an inclusive go-to reference for HPLC method selection, development, and validation. Addresses the various aspects of practice and instrumentation needed to obtain reliable HPLC analysis results Leads researchers to the best choice of an HPLC method from the overabundance of information existent in the field Provides criteria for HPLC method selection, development, and validation Authored by world-renowned HPLC experts who have more than 60 years of combined experience in the field


Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC
Author: Satinder Ahuja
Publisher: Elsevier
Total Pages: 679
Release: 2005-02-09
Genre: Medical
ISBN: 0080455182

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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 a Stability-indicating Method for the Determination of Bendamustine Hydrochloride Using Reversed-phase Liquid Chromatography

Development and Validation of a Stability-indicating Method for the Determination of Bendamustine Hydrochloride Using Reversed-phase Liquid Chromatography
Author: Moizuddin Mohammed
Publisher:
Total Pages: 152
Release: 2016
Genre:
ISBN:

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"Bendamustine Hydrochloride is an anticancer drug classified under alkylating agents. In this research work the reverse-phase HPLC method has been developed. The main focus was to develop a method for routine analysis within a short span of time, with accurate and precise results. The column used was C18 (4.6 x 250 mm, 5μm) and pH 7 maintain at ambient temperature. The flow rate was 1.0mL/min, injection volume 15μL and wavelength was 330nm. The developed method was validated for System Suitability, Specificity, Solution Stability, Robustness, Accuracy, Precision, Linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ)."--