الفهرس 
IntroductionOnly 14 pages are availabe for public view
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Abstract
This part includes general introduction for drugs used in the thesis involving the chemical structure, IUPAC name, molecular formula, molecular weight, physical and pharmacological action of the drugs.
Moreover, it involves litererature reviews which indicates all methods reported for analysis of investigated drugs in raw materials and pharmaceutical dosage form.
This part describes the analysis of single component depending on different techniques either in pharmaceutical dosage form or in raw material
This chapter describes analysis of Tigecycline (TIG), an antimicrobial agent that is indicated for complex bacterial infections, which is recently approved by the FDA as an orphan chemotherapeutic agent for the treatment of acute myeloid leukemia. TIG is mainly administered as intravenous infusion therapy through centralized unit of oncology centers. This necessitates the continuous analytical quality control of the prepared solution in order to identify and quantify TIG for safe intravenous administration to patients. Moreover, the clinical staff exposure risk to toxic drugs during daily handling must be considered. Such concerns require the availability of a fast, cost-effective and green analysis for the sensitive determination of TIG directly in infusion bags. This study presents a simple, rapid and green capillary zone electrophoretic (CZE) method for the sensitive determination of TIG directly in infusion bags. TIG solutions corresponding to the clinical ranges were prepared in 5% glucose. Separation was performed on a deactivated fused silica capillary (56 cm effective length, 50 μm internal diameter (id)) at 245 nm using phosphate buffer pH 2 as running buffer. Also, there are three proposed spectrophotometric methods.
Method I depends on measuring the first derivative spectrophotometric peak-to-peak amplitudes of TIG in methanolic solution at 334–372 nm.
Method II describes the pH-induced difference spectrophotometry (∆A) and its first derivative (∆D1).
This method involves measurement of analytical signal values of TIG in acidic solution against its alkaline solution from peak to peak at 342- 401 nm and 279- 311 nm for ∆A and ∆D1, respectively. Method III is based on the oxidative coupling reaction with 3-methyl-2- benzothiazolinone hydrazone hydrochloride monohydrate (MBTH) in the presence of ceric ammonium sulphate, Ce (IV), as an oxidant to produce colored species with maximum absorbance at 409 nm after 35 min in a thermo-stated water bath at 40oC. All the proposed methods were validated in compliance with ICH guidelines. Comparison of the proposed methods to other reported ones, using Green Analytical Procedure Index (GAPI) and the Eco-scale penalty points approach (PPs), showed that the proposed methods are better eco-friendly methods
This part deals with multi-component analysis to allow separation and determination of mixtures of drugs in their dosage forms, raw materials or in biological fluids.
This chapter describes green validated spectrophotometric methods for simultaneous determination of Azithromycin (AZI) and Levofloxacin (LEVO) antibiotic in their mixture.
Determination of AZI represents a real analytical challenge as its structure lacks any chromophore, and hence it cannot be determined by direct spectrophotometry.
However, the reaction of AZI with perchloric acid produces a green colored product that can be accurately determined spectrophotometrically.
Thus, the work presented demonstrates simple green and sensitive methods for the simultaneous determination of AZI and LEVO in their mixture.
Method I depends on direct measurement of absorbance of azithromycin and levofloxacin in perchloric acid methanolic solution at 482 nm and 224 nm, respectively.
While, Method II depends on measuring the first derivative spectrophotometric peak-topeak amplitudes of AZI and LEVO in perchloric acid methanolic solution at 475-490 nm and 280–253 nm, respectively.
Regression analysis shows good linearity for AZI and LEVO over the concentration ranges of 5 – 50 and 2.5 – 20 μg/mL for method I and 5 – 50 and 5 - 40 μg/mL for method II for AZI and LEVO, respectively.
The proposed methods were validated in compliance with ICH guidelines. The suggested procedures are successfully applied for the assay of AZI and LEVO mixture in bulk powder and laboratory-prepared tablets.
Greenness profile of the proposed methods was compared with other published methods through applying the Eco-scale protocol. Assessment results demonstrated that the proposed methods are greener than other reported methods.
Moreover, upon comparison with other methods, the proposed methods showed better or comparable sensitivity in addition to being selective and rapid with no requirement for laborious extraction techniques. These advantages encourage the application of the proposed methods in routine analysis of AZI and LEVO in quality control laboratories as green and simple analytical tool.
This chapter involves a green capillary zone electrophoretic method (CZE) for analysis of mometasone furoate (MF) and salicylic acid (SAL) simultaneously in synthetic mixtures and topical preparation (Elicasal® ointment) in a ratio of 1: 50 (MF: SAL).
The proposed CZE method showed linear response for both MF and SAL in concentration ranges 0.2 – 40 μg/mL and 0.1 – 80 μg/mL, respectively.
The suggested procedure is successfully used for the accurate and precise determination of the binary mixture in bulk powder and in Elicasal® ointment.
The main advantages of the proposed method are being sensitive, selective, inexpensive and rapid with the use of fewer quantities of solvents and analytical reagents The proposed method was validated according to ICH guidelines. Comparison between the proposed method and reported ones, using Green Analytical Procedure Index (GAPI) and the Eco-scale penalty points approach (PPs), shows that the developed method is a better eco-friendly method than the reported ones
This chapter involves a stability-indicating validated HPTLC method for the determination of Mometasone Furoate (MF) and Salicylic Acid (SAL), simultaneously.
This method was developed to assay the investigated drugs in presence of their degradation products by alkaline, acidic, neutral, photolytic, and oxidative degradation.
The separation was achieved using dual wavelength system, 250 nm for MF and 300 nm for SAL, with mobile phase composed of chloroform: ethanol (9:1 v/v) and stationary phase of aluminum plates pre-coated with silica gel 60 F245. The proposed method is well used for the assay and separation of MF and SAL in pure form and Elicasal® ointment.
The developed method has many advantages such as being rapid, selective and inexpensive.
Such advantages promote the suggested method for the high throughput assay of MF and SAL mixture, in pure form and topical preparation
This chapter describes a sensitive, selective and rapid high performance liquid chromatographic method for simultaneous determination of Moxifloxacin and Metronidazole in different pharmaceutical preparations and biological fluids including human saliva, human plasma and rat plasma without matrix interference.
The separation was performed using isocratic system in acetonitrile and phosphate buffer pH 3 in ratio (30: 70 %v/v) modified with 0.1% triethylamine at 1mL/min as flow rate.
The used detection system was diode array detector that provided the ability of analysis of each drug in its maximum wavelength and ensured purity of drugs. Also, fluorescence detector was used which provided high sensitivity.
This method was validated according to the FDA guidelines for bio-analytical method validation.
Moreover, this work involved comparison with other reported methods where the proposed method was more sensitive and more applicable than the reported ones