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University of Mansoura
Faculty of Pharmacy
Dept. of Analytical Chemistry
Analysis of Some
Chemistry
Antihypertensives and
Vasodilators in Pharmaceutical
Preparations and Biological Fluids.
Thesis Presented By
Rasha Ahmed Abo Shabana Ahmed
B. Pharm. Sci., Mansoura University, 1998
For the Degree of Master in Pharmaceutical Sciences
(Analytical Chemistry)
Under Supervision of
Prof. Dr.
Fawzia Ahmed Ibrahim
Prof. of Analytical Chemistry
Faculty of Pharmacy
University of Mansoura
Prof. Dr.
Dr.
Nahed M. El-Enany
Prof. of Analytical Chemistry
and Dean of Faculty of Pharmacy
University of Mansoura
Shereen M. Shalan
Lecturer of Analytical Chemistry
Faculty of Pharmacy
University of Mansoura
2015
Preface
PREFACE.
The present thesis is devoted for developing new methods for the analysis of
certain antihypertensive drugs, namely: carvedilol (CAR), nebivolol hydrochloride
(NEB), amlodipine besylate (AML), Valsartan (VAL), and aliskiren hemifumarate
(ALS) either in pure form, in pharmaceutical preparations and/or biological fluids. The
principles of the proposed procedures as well as the experimental parameters and
proposal schemes of the reactions were studied, discussed and explained. Furthermore,
the data given were statistically analyzed and compared with those obtained by
comparison methods.
Different analytical techniques were applied for determination of the studied
compounds. The thesis comprises six main parts:
Part I: A general introduction about antihypertensive drugs, their classification, and
their pharmacological actions.
Part II: Two spectrophotometric methods were developed for determination of
carvedilol (CAR) and nebivolol hydrochloride (NEB) in pure form and pharmaceutical
dosage forms depending on the aromatic nucleophilic substitution reaction with 2,4dinitrofluorobenzene and ion-pair complex formation with eosin.
Part III: This part comprises an introduction to spectrofluorimetric and synchronous
spectrofluorimetric methods of analysis of nebivolol and amlodipine besylate. The
present study described fully validated and accurate second derivative synchronous
spectrofluorimetric method for the simultaneous determination of the studied drugs in
their pharmaceutical preparations either alone or in combined dosage form.
Part IV: An accurate and highly sensitive reversed- phase liquid chromatographic
method with fluorimetric detection was developed for the simultaneous determination
of nebivolol hydrochloride and valsartan. The method was applied for the analysis of
studied drugs in their single and laboratory prepared co-formulated dosage forms. The
method was further applied to the determination of valsartan in spiked human plasma
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Preface
with simple pretreatment procedure.
Part V: This part involved the development of rapid, simple and highly sensitive
stability‐indicating spectrofluorimetric method for the determination of aliskiren
hemifumarate in their tablets and human urine. The method was utilized to investigate
its stability and the kinetics of its degradation using different stress conditions according
to ICH Guidelines.
Part VI: Valsartan and aliskiren hemifumarate were also determined by reversedphase liquid chromatographic method with fluorimetric detection. The method was
applied for the analysis of studied drugs in their single and laboratory prepared coformulated dosage forms. The method was further applied to the analysis of studied
drugs in spiked human plasma with simple pretreatment procedure.
The thesis consists of six main parts including (265) references, (48) tables,
(50) figures, and (3) schemes and ends with an Arabic summary.
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