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Document Type |
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Thesis |
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Document Title |
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STABILITY INVESTIGATION OF ANTICANCER DRUG البحث في ثبات المركبات السرطانيه |
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Subject |
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Faculty of Science |
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Document Language |
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Arabic |
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Abstract |
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A validated, sensitive stability-indicating liquid chromatography - diode array - mass spectrometry technique was established to quantify ibrutinib (IBR) and its possible products of degradation. To characterize the degradation products (DPs) of IBR, the bulk material was exposed to different stress tests suggested by ICH guidelines, the effect of UV irradiation, oxidation, heat, acid, and base hydrolysis. The drug was separated from its DPs with an Agilent Extend-C18 column with a length of (150 mm × 4.6 mm) and a mean particle size of 3.5 µm. Acetonitrile with 0.1% aqueous formic acid in 40:60 v/v ratio was selected as the mobile phase. A rate of 0.8 mL/min was chosen for the flow of the mobile phase. IBR was monitored simultaneously using diode array detection at 260 nm and ion trap mass spectrometry detector. IBR was found to undergo photolysis and base-mediated hydrolysis. Also, IBR was affected to some extent by oxidation and heat. Both positive and negative MSn scans were applied to characterize the related substances until ±MS3. The potential DPs were including molar ions at +m/z 304.1, 387.2, 442.2, 471.3, formed majorly due to hydrolysis and oxidation reactions. The analytical method was optimized and validation was carried out with the determination of the linearity, the limit of detection, the limit of quantitation, precision, specificity, and robustness. The potential DPs were detected down to a limit of 0.1% w/w in bulk form. |
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Supervisor |
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Dr. Lateefa AlKhateeb |
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Thesis Type |
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Master Thesis |
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Publishing Year |
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1442 AH
2020 AD |
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Co-Supervisor |
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Prof. Alaa Khedr |
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Added Date |
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Saturday, September 12, 2020 |
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Researchers
| أمل علي الزهراني | Alzahrani, Amal Ali | Researcher | Master | |
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