Development and validation of new analytical methods for the determination of some drugs used in treatment of CNS disorders / (Record no. 177218)

MARC details
000 -LEADER
fixed length control field 10458namaa22004451i 4500
003 - CONTROL NUMBER IDENTIFIER
control field EG-GICUC
005 - أخر تعامل مع التسجيلة
control field 20251231094923.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 251230s2025 ua a|||frm||| 000 0 eng d
040 ## - CATALOGING SOURCE
Original cataloguing agency EG-GICUC
Language of cataloging eng
Transcribing agency EG-GICUC
Modifying agency EG-GICUC
Description conventions rda
041 0# - LANGUAGE CODE
Language code of text/sound track or separate title eng
Language code of summary or abstract eng
-- ara
049 ## - Acquisition Source
Acquisition Source Deposit
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
092 ## - LOCALLY ASSIGNED DEWEY CALL NUMBER (OCLC)
Classification number 615.19
Edition number 21
097 ## - Degree
Degree M.Sc
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
Local Call Number Cai01.08.05.M.Sc.2025.Hu.D
100 0# - MAIN ENTRY--PERSONAL NAME
Authority record control number or standard number Hussein Nabil Mahfouz Ghanem,
Preparation preparation.
245 10 - TITLE STATEMENT
Title Development and validation of new analytical methods for the determination of some drugs used in treatment of CNS disorders /
Statement of responsibility, etc. by Hussein Nabil Mahfouz Ghanem ; Supervised Prof. Dr. Asmaa Ahmed El Zaher, Prof. Sally Tarek Mahmoud, Dr. Enas Taha Abdelhamed.
246 15 - VARYING FORM OF TITLE
Title proper/short title اﻟﺘﻄﻮﯾﺮ واﻟﺘﺤﻘﻖ ﻣﻦ ﻓﺎﻋﻠﯿﺔ ﺑﻌﺾ اﻟﻄﺮق اﻟﺘﺤﻠﯿﻠﯿﺔ اﻟﺠﺪﯾﺪة ﻟﺘﻘﺪﯾﺮ ﺑﻌﺾاﻷدوﯾﺔ اﻟﺘﻲ ﺗﺴﺘﺨﺪم ﻓﻲ ﻋﻼج اﻣﺮاض اﻟﺠﮭﺎز اﻟﻌﺼﺒﻰاﻟﻤﺮﻛﺰى
264 #0 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Date of production, publication, distribution, manufacture, or copyright notice 2025.
300 ## - PHYSICAL DESCRIPTION
Extent 137 pages :
Other physical details illustrations ;
Dimensions 25 cm. +
Accompanying material CD.
336 ## - CONTENT TYPE
Content type term text
Source rda content
337 ## - MEDIA TYPE
Media type term Unmediated
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term volume
Source rdacarrier
502 ## - DISSERTATION NOTE
Dissertation note Thesis (M.Sc)-Cairo University, 2025.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Bibliography: pages135–137.
520 #3 - SUMMARY, ETC.
Summary, etc. Based on the principles of green and white analytical chemistry, new <br/>univariate and chemometric-aided UV spectrophotometric techniques were <br/>created for the simultaneous determination of olanzapine (OLA), fluoxetine HCl <br/>(FLU), and its toxic impurity 4-(Trifluoromethyl) phenol (FMP), without the <br/>need for earlier separation. Through dual-wavelength ratio spectrum analysis, <br/>OLA (4-20 ȝg/mL) and FLU (5-50 ȝg/mL) were successfully determined in the <br/>presence of FMP with satisfactory performance characteristics, including 98-<br/>102% accuracy and precision (RSD <2%). the method was complied with ICH <br/>standards. Chemometric techniques, including partial least squares (PLS) and <br/>artificial neural networks (ANNs), demonstrated superior performance with Latin <br/>hypercube sampling (LHS) for systematically generate representative validation <br/>sets, overcoming the limitations of conventional random data. The analytical <br/>methods were validated across concentration ranges of 2-20 ȝg/mL for both OLA <br/>and FMP, and 5-50 ȝg/mL for FLU. The PLS model demonstrated root mean <br/>square errors of prediction (RMSEP) of 0.087, 0.048, and 0.159 for OLA, FMP, <br/>and FLU respectively. Superior performance was observed with ANN, showing <br/>lower RMSEP values (0.056, 0.047, and 0.087), respectively. Environmental <br/>impact was evaluated using multiple assessment tools including NEMI, ESA, <br/>Complex GAPI, AGREE, and RGB 12 metrics., demonstrating strong <br/>environmental compliance. Statistical analysis revealed no significant <br/>differences (P > 0.05) compared to existing methods. The methods were <br/>successfully applied to pure powders and pharmaceutical capsules. <br/>A novel, eco-friendly high performance liquid chromatography (HPLC) <br/>method was developed for the simultaneous determination of pregabalin (PRE), <br/>milnacipran hydrochloride (MIL), and duloxetine hydrochloride (DLU), FDA-<br/>approved fibromyalgia drugs. This method addresses challenges posed by their <br/>structural diversity and PRE's poor UV absorbance. With the aim of reducing run <br/>time and eliminating derivatization, it avoids hazardous reagents and reduces <br/>waste. Separation was achieved on a C18 column using a mobile phase of 45% <br/>0.03M sodium dihydrogen phosphate buffer (pH 3.5), 30% acetonitrile, and 25% <br/>methanol at flow rate 0.9 ml/min, with UV detection at 210 nm. The method <br/>showed extended linearity (100–1600 μg/ml for PRE, 2–40 μg/ml for MIL and <br/>DLU) and quantification limits of 91.2, 1.326, and 1.872 μg/ml, respectively. <br/>Validated per ICH guidelines and applied to pure drugs and formulations, its <br/>sustainability was confirmed by AGREE and Complex GAPI greenness <br/>assessments. <br/>An innovative chemometrics-assisted UV spectrophotometric methods <br/>for simultaneous quantification of cinnarizine (CIN), domperidone (DOM), and <br/>benzophenone (BNZ), a carcinogenic CIN degradation product, achieved without <br/>the need for prior separation. Predictive models using Classical Least Squares <br/>(CLS), PLS, and Multivariate Curve Resolution–Alternating Least Squares <br/>(MCR-ALS) were developed, with a strategically optimized validation set of 13 <br/>mixtures generated via MATLAB’s Candexch algorithm (D-optimal design). <br/>The methods exhibited robust linearity across 4–20 μg/mL (CIN), 3–15 μg/mL <br/>(DOM), and 1–5 μg/mL (BNZ). Calibration performance was excellent, with root <br/>mean square errors of calibration (RMSEC) values of 0.036–0.062 (CLS), 0.013–<br/>0.024 (PLS), and 0.009–0.012 (MCR-ALS), with MCR-ALS demonstrating the <br/>highest accuracy and stability. Validation confirmed recovery rates of 98–102%, <br/>while RMSEP values for the validation set ranged from 0.042–0.201 (CLS), <br/>0.035–0.187 (PLS), and 0.022–0.154 (MCR-ALS), with MCR-ALS consistently <br/>outperforming other methods in predictive accuracy. Environmental <br/>sustainability was extensively assessed using NEMI, Complex GAPI, AGREE, <br/>BAGI, RGB12, Spider Chart, Carbon Footprint Analysis, GSST, and the NQS <br/>Index, confirming exceptional eco-friendliness and alignment with (UN-SDGs). <br/>A novel environmentally friendly analytical method utilizing Fourier <br/>Transform Infrared (FTIR) spectroscopy was developed for the simultaneous <br/>quantification of CIN and DOM without the need for prior separation. The <br/>approach is based on analyzing the first derivative spectra within the infrared <br/>range of 4600–FPၱï&,1LVTXDQWLILHGDWFPၱïZKHUH'20]HUR<br/>FURVVLQJDQG'20LVGHWHUPLQHGDWFPၱïZKHUH&,1VKRZV]HURFURVVLQJ<br/>The method exhibited excellent linearity within the concentration ranges of 0.6-<br/>3.3 μg/mg for CIN and 0.4–2.4 μg/mg for DOM. Additionally, the limits of <br/>detection (LOD) for both drugs were determined to be 0.171 and 0.128 μg/mg <br/>for CIN and DOM respectively, confirming the method’s sensitivity. The <br/>developed method was validated according to ICH guidelines and successfully <br/>applied to both pure substances and pharmaceutical formulations.
520 #3 - SUMMARY, ETC.
Summary, etc. تقدم هذه الرسالة استراتيجية تحليلية شاملة لتحديد كميات الخلطات الصيدلانية المعقدة المستخدمة في علاج اضطرابات الجهاز العصبي المركزي (CNS).تدمج هذه الاستراتيجية تقنيات التحليل الطيفي المتقدمة، وبشكل خاص التحليل الطيفي بالأشعة فوق البنفسجية (UV) والتحليل الطيفي بالأشعة تحت الحمراء باستخدام تحويل فورييه (FTIR) ، مع طرق الكروماتوغرافيا مثل الكروماتوغرافيا السائلة عالية الأداء (HPLC) .تستخدم الدراسة طرق احادية مثل طيف النسبة ذو الطول الموجي المزدوج ، وتحليل الطيف المشتق، بالإضافة إلى عدد من أدوات الكيمياء الحسابية (الكيمومتريكس) ، بما في ذلك المربعات الصغرى الكلاسيكية (CLS) ، والمربعات الصغرى الجزئية (PLS) ، والشبكات العصبية الاصطناعية (ANNs) ، وحل المنحنيات المتعددة المتغيرات - المربعات الصغرى المتناوبة (MCR-ALS)، لتعزيز تفسير البيانات وأداء الطريقة.تم إجراء تصميم التجارب والتحقق من النموذج باستخدام أخذ العينات من الهيبركيوب اللاتيني (LHS) وتصميم D- optimal المنفذ عبر خوارزميةcandexchفي MATLAB. وقد ضمنت هذه الطريقة متانة الطريقة، والدقة، والكفاءة التشغيلية مع الحفاظ على الاستدامة البيئية.أظهرت المنهجيات المطورة دقة عالية، وموثوقية، وكفاءة بيئية، مما يجعلها مناسبة لمراقبة الجودة الصيدلانية الحديثة. تم إجراء تقييمات للون الأخضر، واللون الأبيض، واللون الأزرق، إلى جانب اختيار المذيبات الموجه بواسطة أداة اختيار المذيبات الخضراء (GSST) ومخطط العنكبوت لتقييم مؤشر الخضرة. (SDAGI) أكدت التقييمات باستخدام مؤشر الطرق البيئية الوطنية (NEMI)، ومقياس البيئة التحليلية (ESA)، ومؤشر الإجراءات التحليلية الخضراء التكميليالمعقد (Complex GAPI)، ومقياس الخضرة التحليلية (AGREE)، وتحليل البصمة الكربونية، ومؤشر قابلية الاستخدام الأزرق (BAGI) ، ونموذج الأحمر والأخضر والأزرق 12 (RGB12)، ومؤشر الحاجةو الجودة والاستدامة (NQS)على الالتزام القوي بمبادئ الكيمياء التحليلية الخضراء (GAC) والكيمياء التحليلية البيضاء (WAC). ومواءمته مع أهداف التنمية المستدامة للأمم المتحدة.(UN-SDGs)
530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE
Issues CD Issues also as CD.
546 ## - LANGUAGE NOTE
Text Language Text in English and abstract in Arabic & English.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmaceutical Chemistry
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element الكيمياء الصيدلية
653 #1 - INDEX TERM--UNCONTROLLED
Uncontrolled term UV spectrophotometry
-- Fourier transform infrared (FTIR)
-- high- performance liquid chromatography (HPLC)
-- chemometrics and univariate techniques
-- experimental design
-- environmental sustainability
-- تحليل الأشعة تحت الحمراء بتحويل فورييه (FTIR)
-- التحليل الطيفي بالأشعة فوق البنفسجية (UV)
700 0# - ADDED ENTRY--PERSONAL NAME
Personal name Asmaa Ahmed El Zaher
Relator term thesis advisor.
700 0# - ADDED ENTRY--PERSONAL NAME
Personal name Sally Tarek Mahmoud
Relator term thesis advisor.
700 0# - ADDED ENTRY--PERSONAL NAME
Personal name Enas Taha Abdelhamed
Relator term thesis advisor.
900 ## - Thesis Information
Grant date 01-01-2025
Supervisory body Asmaa Ahmed El Zaher
-- Sally Tarek Mahmoud
-- Enas Taha Abdelhamed
Universities Cairo University
Faculties Faculty of Pharmacy
Department Department of Pharmaceutical Chemistry
905 ## - Cataloger and Reviser Names
Cataloger Name Shimaa
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Thesis
Edition 21
Suppress in OPAC No
Holdings
Source of classification or shelving scheme Home library Current library Date acquired Inventory number Full call number Barcode Date last seen Effective from Koha item type
Dewey Decimal Classification المكتبة المركزبة الجديدة - جامعة القاهرة قاعة الرسائل الجامعية - الدور الاول 30.12.2025 93007 Cai01.08.05.M.Sc.2025.Hu.D 01010110093007000 30.12.2025 30.12.2025 Thesis
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