Thesis (Ph.D)-Cairo University, 2024.

Bibliography: pages 137-145.

In this thesis, fast, simple and sensitive analytical techniques were established for determining various drugs that influence the respiratory system.
These drugs include glycopyrronium bromide, indacaterol acetate, mometasone furoate and selexipag. The drugs were analyzed in bulk, in pharmaceutical formulations, binary mixtures, ternary mixtures, and in presence of impurities. Also, the greenness assessment was performed using four metrices NEMI, ESA, GAPI and AGREE, the results were compared with that of previously published ones
A stability indicating reversed phase high performance liquid chromatography (RP- HPLC/UV) method was developed for the determination of selexipag in presence of its impurities.
Another reversed phase high performance liquid chromatography (RP-HPLC/UV) method was developed and validated for the simultaneous determination of glycopyrronium bromide, indacaterol acetate and mometasone furoate in their fixed dose combination inhaler using experimental design technique by applying Plackett–Burman and face-centered composite design (FCC).
Four sensitive and accurate UV-spectrophotometric methods were developed the simultaneous determination of indacaterol acetate and mometasone furoate. These methods were induced dual wavelength spectrophotometric method, absorption factor method coupled with modified amplitude subtraction method, first derivative spectrophotometric method coupled with amplitude factor method and first derivative ratio spectrophotometric method.
At the end of each section, the validation parameters according to ICH guidelines were summarized. In addition, a statistical comparison between the results of the developed methods and that of the pharmacopeial or reported methods was performed and no significant difference were found.

تم فى هذه الرسالة إستحداث طرق تحليلية مختلفة على درجة من الدقة والسرعة والحساسية للتقدير الكمي لبعض الأدوية المؤثرة على الجهاز التنفسي وهي: سيليكسيباج وجلايكوبيرونيام بروميد وإينداكاتيرول أسيتات وموميتازون فوروات في صورتها النقية وفى مخاليطيها ومع نواتج تحللها وفى مستحضراتها الصيدلية ومقارنتها بالطرق الدستورية أو المرجعية. كما تم دراسة الأثر البيئي للطرق المقترحة باستخدام أربعة طرق وتمت مقارنة النتائج بنتائج الطرق المنشورة سابقا وأثبتت النتائج ان الطرق المقترحة صديقة للبيئة.

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Text in English and abstract in Arabic & English.