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

Download or read book 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 written by Shaista Khan and published by . This book was released on 2017 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."--