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 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."--

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 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 Seperation [sic] of Nine Pharmaceutical Raw Materials Using Reversed- Phase Liquid Chromatogrpahy [sic] and Dryalb® [sic] Simulations in Comparison to Capillary Electrophoresis
Method Development and Validation for Seperation [sic] of Nine Pharmaceutical Raw Materials Using Reversed- Phase Liquid Chromatogrpahy [sic] and Dryalb® [sic] Simulations in Comparison to Capillary Electrophoresis

Author: Monika Rasic

Publisher:

Published: 2018

Total Pages: 272

ISBN-13:

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"A selection of nine random pharmaceutical drugs were made, which included Nimodipine, Nifedipine, Felodipine, Phenindamine Tartrate, Torsemide, Pantoprazole Sodium, Fluconazole, Loratadine and Clotrimazole. A reversed-phase HPLC and a capillary electrophoresis method was developed to separate a mixture of nine pharmaceutical using an Agilent 1260 Infinity High Performance Liquid Chromatography (HPLC) system, Diode Array Detector (DAD), Capillary Electrophoresis (CE), Waters C18 column (250 X 4.6mm, 5 μ), and mobile phase containing solvent A as 25mM Potassium Phosphate Dibasic buffer pH 6, 6.5, and 7, solvent B (65%ACN acetonitrile or 73% MeOH methanol) for HPLC. For CE it contains buffers at different pH of 5.8 or 6.0. with no ACN or MeOH. Dry Lab software with 2D modeling was used for HPLC involving different pH, column temperature, and different proportion of % ACN or MeOH resulted in an optimum pH 6 for 35°C (ACN) and pH 7.67 for 55°C (ACN). The flow rate was 1.00 ml/min and detection wavelength at 260 nm. Capillary electrophoresis show that best separation was achieved at 50mm pH of 6, 0-30KV gradient for 60 minutes. Both studies are still in progress, with in need of validation."--

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."--

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

Published: 2015-08-01

Total Pages: 108

ISBN-13: 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.

Separation Methods in Drug Synthesis and Purification
Separation Methods in Drug Synthesis and Purification

Author: Klara Valko

Publisher: Elsevier

Published: 2020-06-19

Total Pages: 790

ISBN-13: 0444640711

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Separation Methods in Drug Synthesis and Purification, Second Edition, Volume Eight, provides an updated on the analytical techniques used in drug synthesis and purification. Unlike other books on either separation science or drug synthesis, this volume combines the two to explain the basic principles and comparisons of each separation technique. New sections to this volume include enantiomer separation using capillary electrophoresis (CE) and capillary electro- chromatography, the computer simulation of chromatographic separation for accelerating method development, the application of chromatography and capillary electrophoresis used as surrogates for biological processes, and new developments in the established techniques of chromatography and preparative methods. Features descriptions and applications of all separation methods used in the pharmaceutical industry Written by the leading scientists in their respective fields, providing solutions for a wide range of industrial separation problems encountered within the pharmaceutical industry Thoroughly updated with brand new separation science techniques and the latest developments in the established techniques of chromatography

Reversed-phase Separation : Separation of Ten Pharmaceutical Active Ingredients Using Gradient Elution and DryLab® Modeling Simulation
Reversed-phase Separation : Separation of Ten Pharmaceutical Active Ingredients Using Gradient Elution and DryLab® Modeling Simulation

Author: Phillip R. Onagan

Publisher:

Published: 2017

Total Pages: 254

ISBN-13:

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"In this study ten pharmaceuticals were randomly selected, mixed, and dissolved in a 50:50 acetonitrile–water solvent and then separated through reverse phase HPLC. Stock solutions for each drug with a concentration of 1000 ppm were prepared for the experiments. Afterward, through trial and error appropriate concentrations of aliquots for each drug were mixed to obtain good peak size for chromatographic purposes. Most of the research involved various parameters in instrumentation and the mobile phase and were studied throughout the project to obtain optimum separation. These include the selection of UV spectra signals, flow rates, injection volumes, isocratic and gradient percentages and time ramping rates, solubility, mobile phase solvents, buffers, and temperature changes. After each phase of research the experimental data was then tabulated and used with DryLab software to calculate and provide the optimum conditions for separation. Under those conditions the final experiments were conducted and the data was then compared with the DryLab results. At the end of the study the optimum separation conditions were found with the use of an aqueous buffer of 25 millimoles of dibasic phosphate at a pH of 6.05. The temperature was set at 55 degree Celsius, and a linear gradient set at 12 to 90 percent acetonitrile with a run time of 26.2 minutes. The injection volume was set at 10 ul and flow rate at 1.5 ml per minute. Retention times were found to be from 4.42 to 20.56 minutes, and the resolution ranges were from 9.24 to 32.24. The Supelco C18 column used in this project provided an efficiency range from 13,791 to 273,578 plates, and a tailing range from 0.703 to 1.931."--

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."--