Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using RP-HPLC Method and Drylab® Modeling
Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using RP-HPLC Method and Drylab® Modeling

Author: Anamika Das

Publisher:

Published: 2017

Total Pages: 180

ISBN-13:

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"In this research, 8 pharmaceutical drugs were studied including Nifedipine, Oxcarbazepine, Ticagrelor, Elvitegravir, Metoclopramide HCl, Ciprofloxacin HCl, Levofloxacin hemihydrates and Vanillin. Most of these drugs are used as antibiotics and relievers to treat various kinds of diseases such as high blood pressure, chest pain, stroke, heart attack, stomach discomfort and epilepsy seizures. Moreover, one drug is used in the food industry as flavoring. A reversed-phase HPLC method has been developed to separate a mixture of eight pharmaceutical active ingredients and identify them. Aligent 1100 series HPLC system with Diode Array Detector was used with Xterra C18 (250 X 4.6 mm, 5 μm) column made by Waters with a flow rate of 1.0 ml/min. The column temperature was controlled at 55 °C and the detection wavelength was set at 250 nm. A mobile phase consisted of solvent A (25 mM Potassium Phosphate Dibasic buffer at pH 6.57) and solvent B (100% Acetonitrile). DryLab® software with 2D modeling was used to simulate method development results. First, one parameter was chosen such as gradient time, pH and solvent type. Second, two parameters were used such as simulation of gradient time, temperature and ternary solvent to find the optimum segmented gradient of 5.45% organic solvent at time zero which slowly increased to 25.5% in 11 minute and sharply to 78% in 34 minute. Solvent strength was sharply reduced to 5.45% in 30 seconds. The develop RP-HPLC method was validated in terms of robustness and considered as robust."--

Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and Drylab® Modeling
Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and Drylab® Modeling

Author: Jayeshkumar Vasani

Publisher:

Published: 2017

Total Pages: 200

ISBN-13:

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"A reversed-phase HPLC method was developed to separate a mixture of eight pharmaceutical drug substances which included Lidocaine, Meclizine, Ciprofloxacin HCl, Ropivacain HCl, Adifovire dipivoxil, Doxipin HCl, Thiocolchicoside and Trazodone HCl. These drugs are used a local anesthetic, an antihistamine, antimicrobial agent, for to treat Chronic Hepatitis B infection, depression, anxiety, insomnia, and for muscle relaxation. Agilent 1260 infinity HPLC system with Diode Array Detector was used with Waters C18 (250 x 4.6mm, 5 μm) column with mobile phase as solvent A which is 25mM Potassium Phosphate Monobasic buffer with pH 2.5 and solvent B which is 20% methanol and 80% acetonitrile mixture. DryLab® software with 3D modeling involving gradient time, column temperature and proportion of methanol to acetonitrile simulated optimum segmented gradient of 12% organic solvent at time zero which gradually increased to 18% in 11 minutes and then sharply increased to 90% in 9 minutes. Solvent strength remained at 90% for 3 minutes and was sharply reduced to 12% in 30 seconds. The method was developed under the following chromatographic conditions: buffer pH at 2.5, column temperature at 56 oC, flow rate of 1.00 ml/min and detection wavelength at 235 nm. For validation of developed method robustness was studied and developed method considered as robust."--

Method Development and Validation for Separation of Eight Pharmaceutical Raw Materials Using Reversed-phase Liquid Chromatography and Drylab® Simulation
Method Development and Validation for Separation of Eight Pharmaceutical Raw Materials Using Reversed-phase Liquid Chromatography and Drylab® Simulation

Author: Elham Saleh Alshaikh

Publisher:

Published: 2017

Total Pages: 200

ISBN-13:

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"A reversed-phase HPLC method was developed to separate a mixture of eight pharmaceutical active ingredients: Theophline, Lidocaine, pheniramine, Ondanstron HCl, Triprolidine, Chloridiazepoxide and Doxepin HCl.These drugs are used as antibiotics and relievers and some are used to treat different kinds of diseases such as constant and recurrent migraines. Agilent 1100 series system with Diode Array Detector was used with Waters C18 (250 X 4.6mm, 5 μm) column and mobile phase consisted of solvent A (25mM Sodium acetate buffer at pH4) and solvent B (17% Acetonitrile). DryLab® software with 3D modeling which involved gradient time, column temperature and different proportions of acetonitrile resulted in an optimum linear gradient of 17% organic solvent at zero time which slowly increased to 35% in 22 minutes. Solvent Strength was controlled at 50% for 3 minutes and decreased to 17% in 3 seconds. Buffer was chosen at pH4 with column temperature at 53°C, flow rate of 1.00 mL/min and detection wavelength at 270 nm. The developed method was validated in terms of robustness and considered robust."--

Method Development and Validation for Separation of Nine Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and DryLab® Modeling Software
Method Development and Validation for Separation of Nine Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and DryLab® Modeling Software

Author: Lena Ghadimipour

Publisher:

Published: 2018

Total Pages: 226

ISBN-13:

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"A reversed-phase HPLC method was developed to separate a mixture of nine pharmaceutical active ingredients: Ciprofloxacin Hydrochloride, Gatifloxacin Hydrochloride, Levofloxacin Hemihydrate, Metoclopramide Hydrochloride, Pheniramine Maleate, Ropivacaine Hydrochloride, Theophylline Anhydrous, Thiocolchicoside, Trazodone Hydrochloride. These drugs are used as antibiotics and relievers and some are used to treat different kinds of diseases such as constant and recurrent migraines. Agilent 1100 series system with Diode Array Detector was used with Waters C8 (250 X 4.6mm, 5μm) column and mobile phase consisted of solvent A (25mM Potassium Phosphate Dibasic buffer at pH 7) and solvent B (8.4% Acetonitrile). DryLab® software with 3D modeling which involved gradient time, column temperature and different proportions of acetonitrile resulted in an optimum linear gradient of 8.4% organic solvent at zero time which slowly increased to 20.4% and 95% in 17.5 and 25 minute. Then, solvent Strength was controlled at 95% for 5 minute. Buffer was chosen at pH 7 with column temperature at 34oC, flow rate of 1.00 mL/min and detection wavelength at 220 nm. The developed method was validated in terms of robustness and considered robust."--

Dry Lab® Modeling Computer Assisted Method Develoment and Robustness Validation for the Seperation [sic] of Nine Pharmaceutical Active Ingredients Using Gradient Elution Reversed-phase Separation
Dry Lab® Modeling Computer Assisted Method Develoment and Robustness Validation for the Seperation [sic] of Nine Pharmaceutical Active Ingredients Using Gradient Elution Reversed-phase Separation

Author: Shaista Khan

Publisher:

Published: 2017

Total Pages: 280

ISBN-13:

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"High performance liquid chromatography (HPLC) method development is a technique for drug analysis that is a time consuming process. To prevent the need for a trial and error process, one can use a computer assisted method. In this thesis, we report about the use of Dry Lab to develop and optimize reverse phase liquid chromatography method to separate the following 10 drugs: 1. Clonidine 2. Gatifloxacin 3. Hydrochlorothizaide 4. Triprolidine 5. Fluoconozole 6. Trazodone 7. Pantaeprozole 8. X-Drug 9. Rivarzaban and 10. Ketorolac. Chromatographic separation of mixture of the above drugs was achieved by applying Gradientelution technique at a flow rate of 1.0 ml/min. The organic solvent of choice was ACN and the mobile phase was optimized at a composition of 30% ACN and 70% buffered deionized water. The best suited buffer was a monobasic potassium phosphate salt at a concentration of 25 mm and the mobile phase pH was set 2.88 pH. The separation was performed on a reversed phase, silica based, C8column(250x4.6mm) made by Waters Corporation®, with a particle size of 5 μm. The column temperatures were controlled at 35°C and 55°C; the UV absorption wavelength initially was set at 260, 267 and 290nm, and finally 260nm. The injected volume of a mixture of the above drugs was 10 μl and the total run time for the method was 24 minutes. The method was validated within ICH and FDA guidelines."--

Analytical Method Development and Validation
Analytical Method Development and Validation

Author: Michael E. Swartz

Publisher: CRC Press

Published: 2018-10-03

Total Pages: 95

ISBN-13: 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.

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: Anchor Academic Publishing (aap_verlag)

Published: 2014-08

Total Pages: 114

ISBN-13: 395489307X

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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.

Handbook of Analytical Validation
Handbook of Analytical Validation

Author: Michael E. Swartz

Publisher: CRC Press

Published: 2012-04-24

Total Pages: 226

ISBN-13: 0824706897

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Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

Method Validation in Pharmaceutical Analysis
Method Validation in Pharmaceutical Analysis

Author: Joachim Ermer

Publisher: John Wiley & Sons

Published: 2014-11-10

Total Pages: 451

ISBN-13: 3527335633

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This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Development of Novel Stability Indicating Methods Using Liquid Chromatography
Development of Novel Stability Indicating Methods Using Liquid Chromatography

Author: Mukesh Maithani

Publisher: Springer

Published: 2019-08-07

Total Pages: 101

ISBN-13: 9811387230

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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.