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العنوان
Analytical study of certain antihemorrhagic drugs in their pure forms and pharmaceutical formulations /
المؤلف
Mohammed, Ebtehal Fouly Anwer.
هيئة الاعداد
باحث / ابتهال فولى أنور محمد
مشرف / محمود أحمد عمر
مشرف / سيد محمد سيد علي دريع
مشرف / دينا أحمد مختار نور الدين
الموضوع
Analytical chemistry.
تاريخ النشر
2022.
عدد الصفحات
122 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الصيدلة ، علم السموم والصيدلانيات
تاريخ الإجازة
1/1/2022
مكان الإجازة
جامعة المنيا - كلية الصيدلة - الكيمياء التحليلية
الفهرس
Only 14 pages are availabe for public view

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Abstract

In the present thesis, two antihemorrhagic antifibrinolytic drugs namely tranexamic acid and 6-aminocaproic acid were determined spectrofluorimetrically by applying several approaches. The presented thesis consists of two parts:
Part I: General introduction
This part principally provides a general introduction about the studied drugs such as pharmaceutical indications, chemical structures and analytical review for the reported methods for their determination of the studied drugs in pure form, pharmaceutical formulations as well as biological fluids. At the end of this part, the objective of the suggested work had been described.
Part II: this part is divided into four chapters
Chapter I. Spectrofluorimetric approach for determination of tranexamic acid and 6-aminocaproic acid by using 4-chloro-7-nitro benzofurazan (NBD-Cl).
In this chapter a novel, sensitive and low cost spectrofluorimetric method was created for determination of TXA and ACA. The nucleophilic substitution interaction between the primary amine of TXA or ACA with 4-chloro-7-nitro benzofurazan (NBD-Cl) generated a yellow - color product. The reaction proceeded in borate buffer (pH 9) and its fluorescence has been measured at 536 or 525 nm after excitation at 470 or 472 nm for TXA or ACA, respectively. All the parameters that have an impact on the performance of the developed method were investigated and optimized. The range of linearity were 20.0-100 ng/mL for TXA and 0.1 – 0.7 μg/mL for ACA. The quantitation limit was down to 12.4 ng/mL for TXA and 0.101 μg/mL for ACA and limit of detection of 4.09 ng/mL for TXA and 0.033 μg/mL for ACA.
This approach was effectively employed to evaluate the content of TXA in its tablets and ampoules and ACA in laboratory prepared tablets without any interference from thier excipients. Moreover, the proposed method was extended to determine TXA and ACA in spiked human plasma and urine.
Chapter II. A rapid spectrofluorimetric method based on use of fluorescamine for determination of tranexamic acid and 6-aminocaproic acid.
The presented chapter describes an ingenious approach for determination of TXA or ACA spectrofluorimetrically was developed. This experiment was very simple, sensitive and selective method for determination of TXA or ACA in pure form, pharmaceutical dosage forms and also in spiked human plasma and urine. All optimal conditions needed in the proposed method have been validated precisely. The developed method was based on the reaction between the primary amino group found in the chemical structure of the studied drugs with the fluorescamine reagent in presence of borate buffer (pH is 8.3 or 8.7 for TXA or ACA, respectively). The formed fluorescent product has been measured at 473 nm for TXA or 472 nm for ACA after excitation at 392 nm for TXA or 390 nm for ACA. The linearity of the resulted calibration curve was found to be (0.1-0.9 μg/mL) for TXA and (0.3-1.5 μg/mL) for ACA. LOD and LOQ results 0.024 and 0.072 for TXA and 0.077 and 0.235 for ACA, respectively.
The validation of the developed method was carried out including linear range, accuracy, precision, robustness, limit of detection and quantitation. Finally, the developed method was applied for in vitro determination of TXA and ACA in spiked human plasma and urine as well as in its pharmaceutical dosage forms (tablets and ampoules for TXA and laboratory prepared tablets of ACA).