Application of advanced analytical techniques for quality assessment of selected drugs contain amino group /
تطبيق تقنيات تحليلية متقدمة لتقييم جودة أدوية مختارة تحتوي على المجموعة الأمينية
by Mai Mohamed Talaat Ahmed ; Supervision Prof. Dr. Hala Elsayed Zaazaa, Prof. Dr.Nahla Sayed Ismail Asst. Prof. Dr.Shereen Ahmed Boltia.
- 54 pages : illustrations ; 25 cm. + CD.
Thesis (Ph.D)-Cairo University, 2025.
Bibliography: pages 12-14.
This thesis focuses on the quantitative analysis of certain drugs containing an amino group, such as Teriflunomide and Dorzolamide HCl, whether alone or in combination with Timolol Maleate, respectively. The objective of this research was to develop reliable, rapid, simple, sensitive, precise, and robust methods for determining the analytes with high accuracy and precision. These methods are intended for routine analysis in both bulk and pharmaceutical dosage forms.
Two rapid, accurate, precise, and sensitive stability-indicating high-performance chromatographic methods were developed and validated for estimating Teriflunomide in the presence of its degradation products. The structures of the degradation products were elucidated using LC-MS. Additionally, two simple UV spectrophotometric methods were employed to determine Teriflunomide in the presence of its degradation products (pharmacopeial impurities). The first method involved measuring absorbance spectra from 200 to 400 nm, using one of the impurities as a divisor, followed by constructing the first derivative curve of the ratio spectrum. The second method was the dual wavelength method for the drug ratio spectra. Three innovative carbon paste electrodes were constructed to measure Dorzolamide HCl in both its active pharmaceutical ingredient (API) form and in pharmaceutical preparations containing Timolol Maleate. These included a conventional carbon paste electrode (I), a modified carbon paste electrode incorporating Silica (II), and another modified carbon paste electrode incorporating β-cyclodextrin (III). This research is based on the interaction between Dorzolamide HCl and phosphomolybdic acid to form an electroactive dorzolamide-phosphomolybdate ion exchanger, with dibutylphthalate used as a solvent mediator. ﺗﺘﻨﺎول ھﺬه اﻟﺮﺳﺎﻟﺔ دراﺳﺔ ﺗﺤﻠﯿﻠﯿﺔ ﻟﺒﻌﺾ أدوﯾﺔ ﺗﺤﺘﻮي ﻋﻠﻰ ﻣﺠﻤﻮﻋﺔ الامينو ﺳﻮاء ﻣﻨﻔﺮدة أو ﻓﻲ مخاليط. وﻗﺪ ﺗﻢ اﺧﺘﯿﺎر ﺑﻌﺾ اﻟﻤﺮﻛﺒﺎت وھﻲ تيريفلونومايد بالاضافة الي خليط من الدورزولامايد هيدروكلوريد و تيمولول ماليات واﻟﮭﺪف ﻣﻦ ھﺬه اﻟﺮﺳﺎﻟﺔ ھﻮ اﺳﺘﻨﺒﺎط طﺮاﺋﻖ ﺟﺪﯾﺪة ﺗﺘﻤﯿﺰ ﺑﺎﻟﺒﺴﺎطﺔ واﻟﺪﻗﺔ ودرﺟﺔ اﻟﺤﺴﺎﺳﯿﺔ اﻟﻤﻨﺎﺳﺒﺔ ﻟﺘﺤﻠﯿﻞ ھﺬه اﻟﻤﺮﻛﺒﺎت ﻓﻲ وﺟﻮد ﻧﻮاﺗﺞ ﺗﺤﻠﻠﮭﺎ و/أو اﻟﺸﻮاﺋﺐ وﻛﺬﻟﻚ ﻓﻲ وﺟﻮد أدوﯾﺔ أﺧﺮى، وإﻣﻜﺎﻧﯿﺔ ﺗﻄﺒﯿﻖ اﻟﻄﺮاﺋﻖ اﻟﻤﺴﺘﺤﺪﺛﺔ ﻟﺘﺤﻠﯿﻞ اﻷدوﯾﺔ اﻟﻤﺨﺘﺎرة ﻓﻲ ﻣﺴﺘﺤﻀﺮاﺗﮭﺎ اﻟﺼﯿﺪﻟﯿﺔ وﻣﻘﺎرﻧﺘﮭﺎ ﺑﺎﻟﻄﺮاﺋﻖ اﻟﻤﺮﺟﻌﯿﺔ. ﺗﺤﺘــﻮي ھــﺬه اﻟﺮﺳــﺎﻟﺔ ﻋﻠــﻰ اربعة أﺟــﺰاء ﺗﺘﻀــﻤﻦ اﻟﺘــﺮاث اﻟﻌﻠﻤــﻲ واﻟﺪراﺳــﺔ اﻟﻌﻤﻠﯿــﺔ كما تحتوي علي اثنان و عشرون صورة و ثمانية عشر جدول وسبعون مرجع.