Development of Novel Stability Indicating Methods Using Liquid Chromatography (eBook)

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.  

Dr. Mukesh Maithani, M.Pharma., Ph.D. in pharmaceutical sciences is a Scientist working with the Multidisciplinary Research Unit (ICMR), University Center of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, India. He received the Young Scientist Award from the All India Medicos Society during its 26^th National Medical Congress in 2011 and has more than 12 years experience as a Research Scientist at Zydus Research Centre, Ahmadabad; and as a Senior Research Scientist at the Analytical Development Laboratory, Alembic Research Centre, Vadodara.

Dr. Maithani has made major contributions to pharmaceutical analysis, herbal formulations, and the standardization of drugs. His expertise includes drug discovery, novel analytical techniques, herbal excipients and drugs, targeted drug delivery etc. He has published more than thirty papers in national and international journals and conference proceedings, and is a co-author of seventeen books/book chapters. In addition, Dr. Maithani serves as a reviewer and advisory board member for several international and national journals.

Dr. Parveen Bansal, Ph.D. (Biochemistry), FRSM, FICA (USA), Joint Director, Baba Farid University of Health Sciences, has more than 23 years experience in various positions including Assistant Director/Founder Head of the National Institute of Ayurvedic Pharmaceutical Research. He represented India as a member of the 23^rd Indian Scientific Expedition to Antarctica. He holds three Young Scientist Awards, a Gold Medal from Gujarat Ayurveda University, Jamnagar, an Honorary Fellowship from the International Council of Ayurveda (USA), and a WHO In-country Fellowship from the World Health Organization. He has been nominated as a Member of the Screening Committee for the Cancer Consortium R&D Program, Department of Biotechnology, GOI, has published more than 170 research papers, 17 books and 46 book chapters, and serves as a reviewer or editorial board member for 35 high-impact international journals.

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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.