Stability Indicating Method Development and Validation for the Determination of Felodipine Raw Material and Degradant Products by Utilizing Reversed-phase Liquid Chromatography PDF Download
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Author: Kanan Patel
Publisher:
ISBN:
Category : Dihydropyridine
Languages : en
Pages : 186
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Book Description
"Felodipine, USP is a dihydropyridine calcium antagonist. The brand names for Felodipine are Feloday, Plendil, and Hydec. It is described as an antihypertensive vasodilator agent. A stability indicating reversed phase high performance liquid chromatography has been developed and validated for the determination of Felodipine in a raw material. Agilent 1100 series high performance liquid chromatography system was used for method development studies. The separation was performed on Phenomenex Synergi C18 (4μm), 150 x 4.6 mm column with flow rate 1 mL/min at 25°C column temperature. Isocratic elution was carried out with mobile phase consisted of Solvent A (25mM mono-basic Potassium Dihydrogen Phosphate, pH 2.5) and Solvent B (50% ACN). The UV detection wavelength was set at 235 nm. The stability study of Felodipine was carried out by forced degradation using hydrochloric acid, sodium hydroxide, hydrogen peroxide, UV light, and heat. The correlation coefficient was 0.9996 which indicates linear regression curve. The percentage recovery of the method was 99-100%. The percentage RSD for method precision for peak area and retention time was 1.12 and 0.42, respectively. (n=6). The LOD and LOQ result was found to be 0.01 ppm and 0.05 ppm respectively. The developed method is specific, linear, precise, accurate, and robust based on validation results according to ICH guidelines."--
Author: Kanan Patel
Publisher:
ISBN:
Category : Dihydropyridine
Languages : en
Pages : 186
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Book Description
"Felodipine, USP is a dihydropyridine calcium antagonist. The brand names for Felodipine are Feloday, Plendil, and Hydec. It is described as an antihypertensive vasodilator agent. A stability indicating reversed phase high performance liquid chromatography has been developed and validated for the determination of Felodipine in a raw material. Agilent 1100 series high performance liquid chromatography system was used for method development studies. The separation was performed on Phenomenex Synergi C18 (4μm), 150 x 4.6 mm column with flow rate 1 mL/min at 25°C column temperature. Isocratic elution was carried out with mobile phase consisted of Solvent A (25mM mono-basic Potassium Dihydrogen Phosphate, pH 2.5) and Solvent B (50% ACN). The UV detection wavelength was set at 235 nm. The stability study of Felodipine was carried out by forced degradation using hydrochloric acid, sodium hydroxide, hydrogen peroxide, UV light, and heat. The correlation coefficient was 0.9996 which indicates linear regression curve. The percentage recovery of the method was 99-100%. The percentage RSD for method precision for peak area and retention time was 1.12 and 0.42, respectively. (n=6). The LOD and LOQ result was found to be 0.01 ppm and 0.05 ppm respectively. The developed method is specific, linear, precise, accurate, and robust based on validation results according to ICH guidelines."--
Author: Hiteshi Solanki
Publisher:
ISBN:
Category : High performance liquid chromatography
Languages : en
Pages : 162
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Book Description
"Nimodipine is the latest Calcium channel blocker. It is used for the prevention of major complications of subarachnoid hemorrhage called vasospasm. A simple, linear, accurate, precise, robust reversed-phase HPLC method was developed for the determination of nimodipine raw material on Alltech Krommacil C18 column (250 × 4.6 mm × 5 μm) using mobile phase 50% ACN and 50% Potassium Phosphate Monobasic buffer 25mM at pH 2.5. Total run time was 30 min, flow rate was 1ml/min, injection volume was 10μl and detection wavelength was 237nm. Degradation study was done under different stress conditions: acid hydrolysis, base hydrolysis, oxidation, UV light, heat. The optimum degradation was obtained with 2M HCl, 0.1M NaOH heated for 6hr and 0.5% H2O2 heated for 2hr. Moreover, the developed method was validated as per ICH guidelines for system suitability, specificity, stability, robustness, linearity, accuracy, precision, also for limit of detection and limit of quantitation and this method met all the acceptance criteria."--
Author: Lubna Masu
Publisher:
ISBN:
Category : Anticonvulsants
Languages : en
Pages : 160
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Book Description
Author: Najeeb Eseed
Publisher:
ISBN:
Category : Gastric acid
Languages : en
Pages : 170
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Book Description
Author:
Publisher:
ISBN:
Category : Jerusalem
Languages : en
Pages :
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Book Description
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
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Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Author: Ajit S Narang
Publisher: Springer
ISBN: 3319202065
Category : Medical
Languages : en
Pages : 700
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Book Description
In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.
Author: Yuri V. Kazakevich
Publisher: John Wiley & Sons
ISBN: 0470087943
Category : Science
Languages : en
Pages : 1136
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Book Description
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.
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080554199
Category : Medical
Languages : en
Pages : 533
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Book Description
High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
