الفهرس 
General IntroductionOnly 14 pages are availabe for public view
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Abstract
preparations, covering different matrix composition, without any preconcentration and using isocratic reversed phase HPLC as the analytical method.
The thesis consists of three parts and general introduction:
General Introduction
The general introduction includes chemical structures and physical properties
of the 5 investigated drugs, their analyzed products and composition.
Part I:
This part deals with cleaning validation. It consists of an introduction and two chapters:
Introduction: It includes the importance of cleaning validation in the pharmaceutical industries, guidelines regulating the cleaning validation study, residual limits allowed on the equipment pieces, worst case selection and the different sampling methods.
Chapter I: The chapter deals with the development and validation of a liquid chromatographic method for determination of reserpine residues for cleaning validation in solid dosage production line.
It includes an introduction covering the different steps in choosing the worst case product in the solid dosage form production line, pharmacological action and uses of reserpine and a literature review of the analytical methods for reserpine assay.
It describes an accurate and precise HPLC method for the determination of trace level of reserpine in rinse and swab samples with a concentration ranging from 0.024-0.32 μg/ mL. The developed method was also tested for specificity and applied on the equipment after cleaning. The level of contamination was monitored during several consecutive runs and found to be less than 0.8 μg per swab which is the maximum allowable limit of contamination.
Chapter II: This chapter deals with the quantitative determination of residual indomethacin on equipment surfaces using a validated HPLC-DAD method. It includes an introduction covering the different steps in choosing the worst case product in the semi-solid dosage form production line, pharmacological action, uses of indomethacin and a literature review of the analytical methods for indomethacin assay. The establishment of the cleaning limit acceptance level is also discussed in addition of the description of the development and validation of an HPLC method for the determination of trace level of indomethacin in rinse and swab samples with a concentration ranging from 0.072 – 4.8 μg / mL. The developed method was applied on the equipment after cleaning. The level of contamination was monitored during three consecutive runs and found to be less than 12 μg per swab, the maximum allowable limit of contamination.