Trace Level Determination of Mesityl Oxide and Diacetone Alcohol in Atazanavir Sulfate Drug Substance by a Gas Chromatography Method
| Autor: | N. Sreenivas, N. Siva Krishna, G. Himabindu, K. S. R. Pavan Kumar, Kvvn Raju, P. Madhava Reddy, N. Annapurna, Hemant K. Sharma |
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| Rok vydání: | 2016 |
| Předmět: |
Atazanavir sulfate
Analyte Chromatography Correlation coefficient Pharmaceutical Science Mesityl oxide Development 030226 pharmacology & pharmacy law.invention Atazanavir Sulfate 03 medical and health sciences chemistry.chemical_compound Diacetone alcohol 0302 clinical medicine chemistry law Stationary phase 030220 oncology & carcinogenesis Validation Flame ionization detector Gas chromatography GC-FID Research Article |
| Zdroj: | Scientia Pharmaceutica Volume 84 Issue 2 Pages 321-331 |
| ISSN: | 2218-0532 0036-8709 |
| DOI: | 10.3797/scipharm.1507-05 |
| Popis: | A capillary gas chromatography method with a short run time, using a flame ionization detector, has been developed for the quantitative determination of trace level analysis of mesityl oxide and diacetone alcohol in the atazanavir sulfate drug substance. The chromatographic method was achieved on a fused silica capillary column coated with 5% diphenyl and 95% dimethyl polysiloxane stationary phase (Rtx-5, 30 m x 0.53 mm x 5.0 µm). The run time was 20 min employing programmed temperature with a split mode (1:5) and was validated for specificity, sensitivity, precision, linearity, and accuracy. The detection and quantitation limits obtained for mesityl oxide and diacetone alcohol were 5 µg/g and 10 µg/g, respectively, for both of the analytes. The method was found to be linear in the range between 10 µg/g and 150 µg/g with a correlation coefficient greater than 0.999, and the average recoveries obtained in atazanavir sulfate were between 102.0% and 103.7%, respectively, for mesityl oxide and diacetone alcohol. The developed method was found to be robust and rugged. The detailed experimental results are discussed in this research paper. |
| Databáze: | OpenAIRE |
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