The Power of DryLab® Modeling Software in Method Development and Robustness Validation for Separation of Seven Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography
The Power of DryLab® Modeling Software in Method Development and Robustness Validation for Separation of Seven Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography

Author: Ammar Albayati

Publisher:

Published: 2017

Total Pages: 272

ISBN-13:

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"Nine randomly selected pharmaceutical products, which included Ranolazine, Theophylline Anhydrous, Lidocaine, Ropivacaine Hydrochloride, Pheniramine Maleate, Chlordiazepoxide and Ondansetron Hydrochloride. Most of these products are often used as non-opioid analgesics for treatment of migraines. A reversed phase liquid chromatography had been developed in wet chemistry lab for separation of a mixture of these products by using Agilent 1100 series High Performance Liquid Chromatography (HPLC) system, Diode Array Detector (DAD), Waters C18 column (250 X 4.6mm, 5 μm) and mobile phase containing solvent A (25mM Potassium Phosphate Monobasic buffer pH 2.5) and solvent B (Acetonitrile). DryLab® software simulation was also used for method development. Three parameters (3D) were tested including gradient time, buffer pH and temperature. Two DryLab® simulation were achieved, first with Acetonitrile ACN and second with Methanol MeOH. DryLab® method was found more time efficient and cost saving due to the following reasons: Only 18 runs (or less) was used in DryLab® software for simulation, while unlimited runs (at least 30) to develop a method in common wet chemistry lab. Planned conditions with HPLC runs for DryLab® software, while unplanned in wet chemistry lab. Achieve more than one simulation with DryLab® software (optimum condition), while only one optimum condition can achieve in common wet chemistry lab."--

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."--

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."--

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 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 Ten Pharmaceutical Raw Materias [sic] Using Reversed- Phase Liquid Chromatography and Drylab® Simulation
Method Development and Validation for Separation of Ten Pharmaceutical Raw Materias [sic] Using Reversed- Phase Liquid Chromatography and Drylab® Simulation

Author: Rajwa Alghareeb

Publisher:

Published: 2016

Total Pages: 152

ISBN-13:

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"Ten pharmaceutical drugs were studied in this research, which are adenosine, Clonidine , Sumatriptan Succenate ,Ciprofloxacine HCl ,Levofloxacin, Fluconazole, Ketrolac trumethamine ,Pantoprazole sodium and Triprolidine HCl, Most of these drugs are used as antibiotics and relievers, and they are also used to treat different kinds of diseases such as constant and recurrent migraines. A reversed phase liquid chromatography has been developed for separation of a mixture of these ten drugs. Agilent 1100 series High Performance Liquid Chromatography system with Diode Array Detector were used with Thermo BDS Hypersil C18 (250 X 4.6mm, 5 μm) column at a flow rate of 1.00 ml/min. The chromatographic conditions involved a detection wavelength at 270 nm, and mobile phase contains solvent A (25mM Potassium Phosphate Monobasic buffer pH 2.9) and solvent B (Acetonitrile). A linear gradient elution was chosen as the elution mode with 5-95 % gradient range. Dry Lab software was used to simulate method development results. One parameter simulation was chosen to simulate optimum gradient time, pH, and solvent type. Then, two parameters simulation was used to simulate gradient time and ternary solvent. In addition to the above, three parameters simulation was tested including gradient time, temperature and ternary solvent. The develop method was validated in terms of robustness and considered as robust."--

Method Validation in Pharmaceutical Analysis
Method Validation in Pharmaceutical Analysis

Author: Joachim Ermer

Publisher: Wiley-VCH

Published: 2006-03-06

Total Pages: 418

ISBN-13: 3527604472

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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.