HPLC Method for Determination of APIs in pharmaceutical formulation

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Publisher : Lulu.com
ISBN 13 : 1329072863
Total Pages : 65 pages
Book Rating : 4.3/5 (29 download)

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Book Synopsis HPLC Method for Determination of APIs in pharmaceutical formulation by : Parimal Chatrabhuji

Download or read book HPLC Method for Determination of APIs in pharmaceutical formulation written by Parimal Chatrabhuji and published by Lulu.com. This book was released on 2015-04-17 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for writing this basic HPLC book was probably born during the project sanctioned by University Grants Commission - Pune. This book was written as an updated reference guide for busy laboratory analysts and researchers. Topics covered include HPLC operation, method development and validation aspects. This book can serve as a supplementary text for students pursuing a career in analytical chemistry. It describes basic theories and terminologies for the novice and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. A reader with a science degree and a basic understanding of chemistry is assumed.

Handbook of Pharmaceutical Analysis by HPLC

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Author :
Publisher : Academic Press
ISBN 13 :
Total Pages : 688 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by HPLC by : Satinder Ahuja

Download or read book Handbook of Pharmaceutical Analysis by HPLC written by Satinder Ahuja and published by Academic Press. This book was released on 2005 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

HPLC for Pharmaceutical Scientists

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Author :
Publisher : Wiley-Interscience
ISBN 13 : 9780471681625
Total Pages : 0 pages
Book Rating : 4.6/5 (816 download)

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Book Synopsis HPLC for Pharmaceutical Scientists by : Yuri V. Kazakevich

Download or read book HPLC for Pharmaceutical Scientists written by Yuri V. Kazakevich and published by Wiley-Interscience. This book was released on 2007-02-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Stability-indicating HPLC Methods for Drug Analysis

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Publisher : American Pharmacists Association (APhA)
ISBN 13 : 9781582121093
Total Pages : 0 pages
Book Rating : 4.1/5 (21 download)

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Book Synopsis Stability-indicating HPLC Methods for Drug Analysis by : Quanyun A. Xu

Download or read book Stability-indicating HPLC Methods for Drug Analysis written by Quanyun A. Xu and published by American Pharmacists Association (APhA). This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

An Introduction to HPLC for Pharmaceutical Analysis

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Publisher : Lulu.com
ISBN 13 : 0956152805
Total Pages : 150 pages
Book Rating : 4.9/5 (561 download)

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Book Synopsis An Introduction to HPLC for Pharmaceutical Analysis by : Oona McPolin

Download or read book An Introduction to HPLC for Pharmaceutical Analysis written by Oona McPolin and published by Lulu.com. This book was released on 2009-03-01 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Methods on Drug Analysis

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Publisher : Springer Science & Business Media
ISBN 13 : 3642765068
Total Pages : 599 pages
Book Rating : 4.6/5 (427 download)

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Book Synopsis HPLC Methods on Drug Analysis by : Mantu K. Ghosh

Download or read book HPLC Methods on Drug Analysis written by Mantu K. Ghosh and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 599 pages. Available in PDF, EPUB and Kindle. Book excerpt: The dramatic development of chromatographic techniques, specially high per formance or high pressure liquid chromatography (HPLC) has made possible the easy analysis of organic compounds, including drugs and drug components, for last two decades. This rapid increase and improvement of analytical methodology with HPLC has enabled researchers and scientists to cope with other scientific and instru mental developments in their fields of work. Thousands of impressive and original scientific publications, text books and monographs describe the techniques for drug analysis with high performance liquid chromatography. However, no concise presentation of the general proper ties of the drugs and their HPLC methodology exists together in the market. This work contains the general properties necessary for the analysis of 232 drugs as well as the HPLC methods for many other drugs and drug components. It is hoped that it will fill a gap and provide a precise survey of the HPLC methods for drug analysis. It is intended as an immediate guide in the laboratory and will be of help to the scientists, researchers and technicians in the field of analysis.

HPLC in the Pharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 9780824784997
Total Pages : 332 pages
Book Rating : 4.7/5 (849 download)

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Book Synopsis HPLC in the Pharmaceutical Industry by : Godwin W. Fong

Download or read book HPLC in the Pharmaceutical Industry written by Godwin W. Fong and published by CRC Press. This book was released on 1991-03-14 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an

Development of Novel Stability Indicating Methods Using Liquid Chromatography

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Author :
Publisher : Springer
ISBN 13 : 9789811387258
Total Pages : 0 pages
Book Rating : 4.3/5 (872 download)

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Book Synopsis Development of Novel Stability Indicating Methods Using Liquid Chromatography by : Mukesh Maithani

Download or read book Development of Novel Stability Indicating Methods Using Liquid Chromatography written by Mukesh Maithani and published by Springer. This book was released on 2020-08-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

HPLC Methods for Pharmaceutical Analysis, Volumes 2-4

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Author :
Publisher : Wiley-Interscience
ISBN 13 : 9780471332954
Total Pages : 0 pages
Book Rating : 4.3/5 (329 download)

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Book Synopsis HPLC Methods for Pharmaceutical Analysis, Volumes 2-4 by : George Lunn

Download or read book HPLC Methods for Pharmaceutical Analysis, Volumes 2-4 written by George Lunn and published by Wiley-Interscience. This book was released on 2000-04-04 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The most commonly used method for analyzing substances, and the first method most researchers turn to, is high performance liquid chromatography (HPLC). Following up on a best-seller, volumes 2-4 continue to provide an easily-accessible collection of procedures for analyzing pharmaceuticals using HPLC.

Analytical Method Development and Validation

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Publisher : CRC Press
ISBN 13 : 9780824701154
Total Pages : 100 pages
Book Rating : 4.7/5 (11 download)

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Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz

Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 1997-05-16 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Method Validation in Pharmaceutical Analysis

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527335633
Total Pages : 451 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Method Validation in Pharmaceutical Analysis by : Joachim Ermer

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2014-11-10 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

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Publisher : Anchor Academic Publishing (aap_verlag)
ISBN 13 : 395489307X
Total Pages : 114 pages
Book Rating : 4.9/5 (548 download)

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Book Synopsis Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques by : Satish Y. Gabhe

Download or read book Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations: HPLC And HPTLC Techniques written by Satish Y. Gabhe and published by Anchor Academic Publishing (aap_verlag). This book was released on 2014-08 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

High Performance Liquid Chromatography

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Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110529459
Total Pages : 322 pages
Book Rating : 4.1/5 (15 download)

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Book Synopsis High Performance Liquid Chromatography by : Omar Al Sayed Omar

Download or read book High Performance Liquid Chromatography written by Omar Al Sayed Omar and published by Walter de Gruyter GmbH & Co KG. This book was released on 2022-02-21 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book provides an indispensable guide on how to use HPLC in pharmaceutical analysis and drug control. Following a hands-on approach, the authors give practical advices how to prepare stationary and mobile phases, choose a suitable detector and set up an HPLC analysis. The publication gives insight into the key pharmaceutical applications of HPLC and the latest requirements of the major regulatory agencies.

Handbook of Analytical Validation

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Publisher : CRC Press
ISBN 13 : 0824706897
Total Pages : 226 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Handbook of Analytical Validation by : Michael E. Swartz

Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Hplc Method for Detection of Ingredients of Cough and Cold Preparations

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Publisher : LAP Lambert Academic Publishing
ISBN 13 : 9783848412037
Total Pages : 112 pages
Book Rating : 4.4/5 (12 download)

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Book Synopsis Hplc Method for Detection of Ingredients of Cough and Cold Preparations by : Rahul Sahu

Download or read book Hplc Method for Detection of Ingredients of Cough and Cold Preparations written by Rahul Sahu and published by LAP Lambert Academic Publishing. This book was released on 2012-04 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to provide guidance for the development of an analytical method on HPLC for the analysis of active pharmaceutical ingredients of pharmaceutical formulation. Topics included are basic method development and its validation according to ICH guideline. This manual will only cover the use of reverse phase chromatography. HPLC assays are used to demonstrate control of the process, to track and minimize impurities, and to maximize the yield and purity of the isolated product. Characterized working standards are utilized for quantification. In this thesis work has been carried out for the determination of Guaifenesin and Pseudoephedrine hydrochloride in cold and cough preparartios.

Chromatographic Analysis of Pharmaceuticals

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Publisher : Routledge
ISBN 13 : 1351460854
Total Pages : 542 pages
Book Rating : 4.3/5 (514 download)

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Book Synopsis Chromatographic Analysis of Pharmaceuticals by : John A. Adamovics

Download or read book Chromatographic Analysis of Pharmaceuticals written by John A. Adamovics and published by Routledge. This book was released on 2017-09-29 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.

Bioanalysis of Pharmaceuticals

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118716825
Total Pages : 332 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Bioanalysis of Pharmaceuticals by : Steen Honoré Hansen

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.