Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations Hplc And Hptlc Techniques PDF Download

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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
Total Pages: 108
Release: 2015-08-01
Genre: Science
ISBN: 3954898071
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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.

Simultaneous Estimation of Some Drugs in Bulk and in their Formulation by Chromatographic Methods.

Simultaneous Estimation of Some Drugs in Bulk and in their Formulation by Chromatographic Methods.
Author: Satish Gabhe
Publisher: GRIN Verlag
Total Pages: 109
Release: 2014-04-09
Genre: Medical
ISBN: 3656633231
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Master's Thesis from the year 2013 in the subject Medicine - Pharmacology, Pharmacy, , course: MASTER OF PHARMACY (Quality Assurance Techniques), language: English, abstract: A number of new drug entities, modifications of existing ones, and multi-component formulations are entering the market, every year. Development of simple analytical methods for analysis of various drugs in multi - component formulations is a tricky task for an analytical researcher. As analytical techniques are used throughout drug development, manufacturing, release of drug products, the reliability of their results is essential. Chromatographic methods are most useful and powerful techniques for qualitative and quantitative determination of drug/s. Therefore, appropriate validation to demonstrate the performance and suitability of the analytical method is much more than a formal requirement. Hence, there is need to develop and validate correct analytical method for these medicine/s. This book details, - Development and validation of HPTLC - densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. - Development and validation of HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. - Development and validation of RP - HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is better alternative to existing one. 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) guidelines. Developed analytical methods could boost analytical researcher to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

Analytical Method Development and Validation

Analytical Method Development and Validation
Author: Michael E. Swartz
Publisher: CRC Press
Total Pages: 95
Release: 2018-10-03
Genre: Science
ISBN: 1482229773
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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.

Chromatographic Analysis of Pharmaceuticals

Chromatographic Analysis of Pharmaceuticals
Author: John A. Adamovics
Publisher: Routledge
Total Pages: 542
Release: 2017-09-29
Genre: Science
ISBN: 1351460854
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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.

HPLC Methods on Drug Analysis

HPLC Methods on Drug Analysis
Author: Mantu K. Ghosh
Publisher: Springer Science & Business Media
Total Pages: 599
Release: 2012-12-06
Genre: Medical
ISBN: 3642765068
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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.

Development and Validation of HPLC Method for Combined Dosage Form

Development and Validation of HPLC Method for Combined Dosage Form
Author: Digbijay Kumar
Publisher: LAP Lambert Academic Publishing
Total Pages: 108
Release: 2013
Genre:
ISBN: 9783659438691
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Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. This presentation will discuss the development and validation of analytical method Spectrophotometric and High performance liquid chromatography (HPLC), for drug products containing more than one active ingredient. This book deals with various approaches applied for the development and validation of analytical method for paracetamol and pamabrom.

Thin Layer Chromatography in Drug Analysis

Thin Layer Chromatography in Drug Analysis
Author: Lukasz Komsta
Publisher: CRC Press
Total Pages: 1070
Release: 2013-12-20
Genre: Medical
ISBN: 1466507152
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Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date, complete reference, Thin Layer Chromatography in Drug Analysis covers the most important methods in pharmaceutical applications of TLC, namely, analysis of bulk drug material and pharmaceutical formulations, degradation studies, analysis of biological samples, optimization of the separation of drug classes, and lipophilicity estimation. The book is divided into two parts. Part I is devoted to general topics related to TLC in the context of drug analysis, including the chemical basis of TLC, sample pleparation, the optimization of layers and mobile phases, detection and quantification, analysis of ionic compounds, and separation and analysis of chiral substances. The text addresses the newest advances in TLC instrumentation, two-dimensional TLC, quantification by slit scanning densitometry and image analysis, statistical processing of data, and various detection and identification methods. It also describes the use of TLC for solving a key issue in the drug market—the presence of substandard and counterfeit pharmaceutical products. Part II provides an in-depth overview of a wide range of TLC applications for separation and analysis of particular drug groups. Each chapter contains an introduction about the structures and medicinal actions of the described substances and a literature review of their TLC analysis. A useful resource for chromatographers, pharmacists, analytical chemists, students, and R&D, clinical, and forensic laboratories, this book can be utilized as a manual, reference, and teaching source.

Thin Layer Chromatography in Drug Analysis

Thin Layer Chromatography in Drug Analysis
Author: Lukasz Komsta
Publisher: CRC Press
Total Pages: 1067
Release: 2013-12-20
Genre: Medical
ISBN: 1466507160
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Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date

Chromatographic Methods Development

Chromatographic Methods Development
Author: Gregory K. Webster
Publisher: CRC Press
Total Pages: 567
Release: 2019-10-28
Genre: Medical
ISBN: 042951039X
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This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

HPLC Methods for Recently Approved Pharmaceuticals

HPLC Methods for Recently Approved Pharmaceuticals
Author: George Lunn
Publisher: John Wiley & Sons
Total Pages: 743
Release: 2005-05-06
Genre: Science
ISBN: 0471711675
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An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods