Analytical Method Development and Validation By UV and HPLC Techniques. UV, HPLC, Dissolution Methods / Hajera Khan

Public ISBD Titre : Analytical Method Development and Validation By UV and HPLC Techniques. UV, HPLC, Dissolution Methods Type de document : texte imprimé Auteurs : Hajera Khan, Auteur ; Shahed Mirza, Auteur ; Faria khan, Auteur Editeur : LAP Lambert Academic Publishing Année de publication : 2012 ISBN/ISSN/EAN : 978-3-659-24797-2 Langues : Français (fre) Catégories : Pharmacologie Résumé : Gemifloxacin,a flouroquinoline derivative has antibacterial activity. Ambroxol dibromoaminobenzyl derivatives have mucolytic activity.GEM and AMB are available in tablet dosage form (G-cin A,Lupin)for mucolytic action. The present work dealt with simultaneous estimation of GEM and AMB from bulk and tablet formulation by different UV spectrophotometric, RPHPLC and Dissolution techniques. Five UV methods were developed which are accurate, precise, rapid and economical for the estimation of GEM and AMB in Tablet dosage form. The developed HPLC method was validated in terms of accuracy, repeatability, and precision. A good linear relationship was observed for GEM An attempt has been made to carry out the dissolution study of the marketed formulation by applying four established UV-Visible Spectrophotometric methods for estimation of % release of the drug (GEM & AMB). Analytical Method Development and Validation By UV and HPLC Techniques. UV, HPLC, Dissolution Methods [texte imprimé] / Hajera Khan, Auteur ; Shahed Mirza, Auteur ; Faria khan, Auteur . - [S.l.] : LAP Lambert Academic Publishing, 2012. ISBN : 978-3-659-24797-2 Langues : Français (fre) Catégories : Pharmacologie Résumé : Gemifloxacin,a flouroquinoline derivative has antibacterial activity. Ambroxol dibromoaminobenzyl derivatives have mucolytic activity.GEM and AMB are available in tablet dosage form (G-cin A,Lupin)for mucolytic action. The present work dealt with simultaneous estimation of GEM and AMB from bulk and tablet formulation by different UV spectrophotometric, RPHPLC and Dissolution techniques. Five UV methods were developed which are accurate, precise, rapid and economical for the estimation of GEM and AMB in Tablet dosage form. The developed HPLC method was validated in terms of accuracy, repeatability, and precision. A good linear relationship was observed for GEM An attempt has been made to carry out the dissolution study of the marketed formulation by applying four established UV-Visible Spectrophotometric methods for estimation of % release of the drug (GEM & AMB).

Exemplaires (1)

Code-barres	Cote	Support	Localisation	Section	Disponibilité
6368	Pharmaco 15	Livre	Bibliothèque	Pharmacologie	Exclu du prêt

Easy Ways to Understand HPLC, UV and Method Validation Parameters / Mazharul Islam Chowdhury

Public ISBD Titre : Easy Ways to Understand HPLC, UV and Method Validation Parameters Type de document : texte imprimé Auteurs : Mazharul Islam Chowdhury, Auteur Editeur : LAP Lambert Academic Publishing Année de publication : 2013 ISBN/ISSN/EAN : 978-3-659-40239-5 Langues : Français (fre) Catégories : Biochimie Résumé : High-pressure liquid chromatography (HPLC) used in the analytical development to quantify the biological sample concentration, the active pharmaceutical ingredient (API) and to evaluate the impurity and degradation product profiles of the drug substances (DS) and drug products (DP). Additional uses of HPLC include determination of content uniformity of dosage form, monitoring of dissolution profiles, determination of antioxidants and preservative content and supporting of cleaning validations. UV spectroscopy is one of the most frequent used techniques in pharmaceutical analysis. It involves the measurement of UV radiation absorbed by a substance in solution. The wavelength range of UV radiation is 200-400nm (180-380 nm) and the UV radiation has a sufficient energy to excite valance electrons in many atoms or molecules; consequently, UV is involved with electronic excitation. Easy Ways to Understand HPLC, UV and Method Validation Parameters [texte imprimé] / Mazharul Islam Chowdhury, Auteur . - [S.l.] : LAP Lambert Academic Publishing, 2013. ISBN : 978-3-659-40239-5 Langues : Français (fre) Catégories : Biochimie Résumé : High-pressure liquid chromatography (HPLC) used in the analytical development to quantify the biological sample concentration, the active pharmaceutical ingredient (API) and to evaluate the impurity and degradation product profiles of the drug substances (DS) and drug products (DP). Additional uses of HPLC include determination of content uniformity of dosage form, monitoring of dissolution profiles, determination of antioxidants and preservative content and supporting of cleaning validations. UV spectroscopy is one of the most frequent used techniques in pharmaceutical analysis. It involves the measurement of UV radiation absorbed by a substance in solution. The wavelength range of UV radiation is 200-400nm (180-380 nm) and the UV radiation has a sufficient energy to excite valance electrons in many atoms or molecules; consequently, UV is involved with electronic excitation.

Exemplaires (1)

Code-barres	Cote	Support	Localisation	Section	Disponibilité
6362	Bioch 50	Livre	Bibliothèque	Biochimie	Exclu du prêt

Mass Spectrometry for the Clinical Laboratory / Hari Nair

Public ISBD Titre : Mass Spectrometry for the Clinical Laboratory Type de document : texte imprimé Auteurs : Hari Nair, Auteur ; William Clarke, Auteur Editeur : LAP Lambert Academic Publishing Année de publication : 2013 ISBN/ISSN/EAN : 978-0-12-800871-3 Langues : Français (fre) Catégories : Biologie Résumé : Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in clinical labs. It provides readers with practical examples for assay development, and experimental design for validation to meet CLIA requirements, appropriate interference testing, measuring, validation of ion suppression/matrix effects, and quality control. These tools offer guidance on what type of instrumentation is optimal for each assay, what options are available, and the pros and cons of each. Readers will find a full set of tools that are either directly related to the assay they want to adopt or for an analogous assay they could use as an example. Written by expert users of the most common assays found in a clinical laboratory (clinical chemists, toxicologists, and clinical pathologists practicing mass spectrometry), the book lays out how experts in the field have chosen their mass spectrometers, purchased, installed, validated, and brought them on line for routine testing. The early chapters of the book covers what the practitioners have learned from years of experience, the challenges they have faced, and their recommendations on how to build and validate assays to avoid problems. These chapters also include recommendations for maintaining continuity of quality in testing. The later parts of the book focuses on specific types of assays (therapeutic drugs, Vitamin D, hormones, etc.). Each chapter in this section has been written by an expert practitioner of an assay that is currently running in his or her clinical lab. Provides readers with the keys to choosing, installing, and validating a mass spectrometry platformOffers tools to evaluate, validate, and troubleshoot the most common assays seen in clinical pathology labsExplains validation, ion suppression, interference testing, and quality control design to the detail that is required for implementation in the lab Mass Spectrometry for the Clinical Laboratory [texte imprimé] / Hari Nair, Auteur ; William Clarke, Auteur . - [S.l.] : LAP Lambert Academic Publishing, 2013. ISBN : 978-0-12-800871-3 Langues : Français (fre) Catégories : Biologie Résumé : Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in clinical labs. It provides readers with practical examples for assay development, and experimental design for validation to meet CLIA requirements, appropriate interference testing, measuring, validation of ion suppression/matrix effects, and quality control. These tools offer guidance on what type of instrumentation is optimal for each assay, what options are available, and the pros and cons of each. Readers will find a full set of tools that are either directly related to the assay they want to adopt or for an analogous assay they could use as an example. Written by expert users of the most common assays found in a clinical laboratory (clinical chemists, toxicologists, and clinical pathologists practicing mass spectrometry), the book lays out how experts in the field have chosen their mass spectrometers, purchased, installed, validated, and brought them on line for routine testing. The early chapters of the book covers what the practitioners have learned from years of experience, the challenges they have faced, and their recommendations on how to build and validate assays to avoid problems. These chapters also include recommendations for maintaining continuity of quality in testing. The later parts of the book focuses on specific types of assays (therapeutic drugs, Vitamin D, hormones, etc.). Each chapter in this section has been written by an expert practitioner of an assay that is currently running in his or her clinical lab. Provides readers with the keys to choosing, installing, and validating a mass spectrometry platformOffers tools to evaluate, validate, and troubleshoot the most common assays seen in clinical pathology labsExplains validation, ion suppression, interference testing, and quality control design to the detail that is required for implementation in the lab

Exemplaires (1)

Code-barres	Cote	Support	Localisation	Section	Disponibilité
6369	Biologie 38	Livre	Bibliothèque	Biologie	Exclu du prêt

Practical HPLC and LC-MS Method Development and Validation : Guidelines for Pharmaceutical Scientists / Ghulam A. Shabir

Public ISBD Titre : Practical HPLC and LC-MS Method Development and Validation : Guidelines for Pharmaceutical Scientists Type de document : texte imprimé Auteurs : Ghulam A. Shabir, Auteur Editeur : LAP Lambert Academic Publishing Année de publication : 2012 ISBN/ISSN/EAN : 978-3-659-12352-8 Langues : Français (fre) Catégories : Biochimie Résumé : The coherent body of research described in this book is concerned with new HPLC method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC and LC-MS. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide. Practical HPLC and LC-MS Method Development and Validation : Guidelines for Pharmaceutical Scientists [texte imprimé] / Ghulam A. Shabir, Auteur . - [S.l.] : LAP Lambert Academic Publishing, 2012. ISBN : 978-3-659-12352-8 Langues : Français (fre) Catégories : Biochimie Résumé : The coherent body of research described in this book is concerned with new HPLC method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC and LC-MS. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Exemplaires (1)

Code-barres	Cote	Support	Localisation	Section	Disponibilité
6364	Bioch 52	Livre	Bibliothèque	Biochimie	Exclu du prêt

---

1 (1 - 4 / 4)