Development of Novel Stability Indicating Methods Using Liquid Chromatography
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 a
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velopment of Novel Stability Indicating Methods Using Liquid Chromatography
Development of Novel Stability Indicating Methods Using Liquid Chromatography
Mukesh Maithani • Parveen Bansal
Development of Novel Stability Indicating Methods Using Liquid Chromatography
Mukesh Maithani Multidisciplinary Research Unit, University Centre of Excellence in Research Baba Farid University of Health Sciences Faridkot, Punjab, India
Parveen Bansal University Centre of Excellence in Research Baba Farid University of Health Sciences Faridkot, Punjab, India
ISBN 978-981-13-8722-7 ISBN 978-981-13-8723-4 (eBook) https://doi.org/10.1007/978-981-13-8723-4 © Springer Nature Singapore Pte Ltd. 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore
This book is dedicated to my father, Maithani P. Ram, with lots of love. –Mukesh Maithani
Preface
Chemical stability of pharmaceutical molecules is a matter of great concern as it affects the safety and efficacy of the pharmaceutical formulations. The FDA and ICH guidelines state the requirement of stability testing data to understand how the quality of a drug substance and drug product changes with time under the influence of various environmental factors. Stability testing is an essential part of drug development which ensures the quality, safety, and efficacy of the drug for the lifetime of the drug product. Appropriate storage conditions can only be assessed once a stability study has been conducted. Stability studies are a pharmacopoeial requirement, and guidance is provided by the regulatory authorities, including the ICH. It has become mandatory to perform stability studies of new drug moiety before filing in the registrati
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