الفهرس 
PART IOnly 14 pages are availabe for public view
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Abstract
The thesis dealt with the analysis of binary mixture of some pharmaceutical compounds belongs to several pharmacological groups such as beta blocker, diuretics, nonsteroidal anti-inflammatory agent and sympathomimetic drug.
The thesis comprises four main parts:
Part I This part contained a general introduction about the chemical names, structures, molecular formulae and molecular weights, physical properties, pKa, pharmacological actions and therapeutic uses of the studied drugs.
It also contains literature reviews for the pharmacopoeial and other reported methods of analysis for selected drugs in pharmaceutical dosage forms, biological samples and other possible matrices.
<Part II This part dealt with the analysis of binary mixture of oxprenolol hydrochloride and cyclopenthiazide using several spectrophotometric and chromatographic methods. This part included two chapters.
Chapter 1: In this chapter, two spectrophotometric methods were applied for the simultaneous determination of this binary mixture in bulk and their laboratory prepared tablets without prior separation namely zero-crossing derivative and ratio-spectra derivative methods.
The first method was based on the use of derivative spectrophotometry with the zero-crossing technique where cyclopenthiazide was determined by measuring 1D value at 335.5 nm, while oxprenolol hydrochloride was determined by measuring 2D value at 280.5 nm. The second method involved the application of the ratio-spectra derivative spectrophotometry. For determination of cyclopenthiazide, 30 µg/mL oxprenolol was used as a divisor and the 1DR peak to trough at 335.5 nm were plotted against cyclopenthiazide concentrations; while for oxprenolol determination 2 µg/mL cyclopenthiazide as divisor was used and the 1DR peak to trough at 285.5 nm were found to be proportional to oxprenolol concentrations.
Concerning the first and second methods, linearity ranges were 0.2-12 and 10-200 µg/mL for cyclopenthiazide and oxprenolol hydrochloride, respectively with correlation coefficients not less than 0.9999. The developed method was validated with respect to linearity, accuracy, precision and specificity
Chapter 2: A validated and highly selective stability-indicating high-performance layer chromatography (HPLC) method was developed for the simultaneous determination of oxprenolol hydrochloride and cyclopenthiazide binary mixture in bulk drug and in combined dosage forms.
Effective chromatographic separation was achieved on Zorbax Eclipse SB-C18 analytical column (250 x 4.6 mm, 5µm) using isocratic elution with a mobile phase consisting of acetonitrile and 50 mM sodium dihydrogen phosphate buffer adjusted to pH 3.5 in a ratio of 50:50 (v/v).
The separation was carried out at ambient temperature with a flow rate 1.0 mL/min. Quantitation was achieved with photodiode array detection at 224 nm for both drugs based on measuring the peak areas. The cited drugs were resolved with retention times 4.34 and 6.73 min for oxprenolol and cyclopenthiazide, respectively. Analytical performance of the proposed HPLC procedure was thoroughly validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection and quantification limits. The linearity ranges were 1-300 and 0.1-150 µg/mL for oxprenolol and cyclopenthiazide, respectively with correlation coefficients not less than 0.999.
The drugs were subjected to stress conditions of acidic and alkaline hydrolysis, oxidation, photolysis and thermal degradation. The proposed method proved to be stability-indicating by resolution of the drugs from their forced degradation products.
The method was successfully applied to the analysis of the drugs in their synthetic mixtures and laboratory prepared tablets. The mean percentage recoveries were in the range of 98-102% and the RSD% did not exceed 2%. The method was validated according to ICH guidelines and showed good performances in terms of linearity, sensitivity, precision, accuracy, and stability.
The results obtained by spectrophotometric and HPLC methods were statistically comparable by ANOVA test. No significant difference was recorded between the mean percent levels determined by the proposed methods