Arsi UNIVERSITY College of health science

PHARMACY DEPARTMENT
Pharmaceutical Analysis -I COURSE SYLLABUS AND COURSE OUT LINE

Course Title: Pharmaceutical Analysis I

Course No.: Phar 231
Credit hours: 4 hrs

Course description:
After completing the two courses, students will able to describe; pharmaceutical analysis,
importance of quality control, steps involved in drug analysis, sample pretreatment, different
analytical methods and their use in pharmaceutical analysis. They will also able to propose
suitable analytical technique for a sample, carry out analysis for different pharmaceuticals as
well as handle, interpret and report data obtained from the analysis.

Course objective:
To enable students understand the purpose of pharmacopoeia and quality control and to provide
proper knowledge on the application of classical methods in the analysis of drugs.

Logistics:
Location: AU College of Health Science main campus class Room- Adjusted
Practical - Pharmacy demonstration room
Length: From 01/04/2009 EC - 10/ 07/ 2009 EC
Date of the course: Theory- Sunday 8:00- 11:50 AM

Teaching Methods:
 Lecture(48 lecture hrs)
 Reading assignment and seminar ( 6 hrs: 3 hrs. x 2 weeks)
 Laboratory classes (36 hrs: 3 hrs x 12 weeks)
Assessment Methods:
 Assignments (10%)
 Laboratory exercise 20 %( Lab. Reports 10%; Lab. Exam. 10%)
 Written examination 70% (Tests 30%; final exam. 40%)

Course references:
Books Recommended:
1. Beckett, A.H. and Stenlake, J.B. Practical Phamaceutical Chemistry, Parts I, 4th
edn., The Athlone Press, London, 1988.
2. Connors, K.A. Textbook of Pharmaceutical Analysis, 3rd edition., 1982

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 3. David G. Watson. Pharmaceutical Analysis, A Textbook for Pharmacy Students and
Pharmaceutical Chemists, 2nd Edition, 2005, Elsevier.
4. Gary D. Christian; Analytical chemistry, 6th edition, John Wiley and Sons INC., USA,
2004
5. British pharmacopoeia ;volume I and II
6. United state pharmacopoeia
7. D.C Garratt; The quantitative Analysis of drugs, 2003, 3rd or latest edition

Course Outline
Chapter 1: Introduction to pharmaceutical analysis (6 hrs)
1.1.Definitions
1.2.Introduction to quality control and Quality Assurance
1.3.The compendia
1.3.1.Pharmacopoeia and other official methods
1.3.2.General notices
1.3.3.Monographs
1.4 Analytical Errors
1.5 Validation of Analytical procedures
1.6 Basic calculations in pharmaceutical analysis
1.6.1 Percentage:
o Percentage volume/volume (% V/V)
o Percentage weight/volume (% W/V)
o Percentage weight/weight (% W/W)
1.6.2 Parts per million (ppm) and parts per billion (ppb)
1.6.3 Molarity (M)
1.6.4 Normality (N)
1.6.5 Dilutions
1.7 Physical and chemical properties of drug molecules
1.7.1 Calculation of pH
1.7.2 Acidic and basic strength and PKa
1.7.3 Buffers
Chapter 2: Sample preparation for analysis (2 hr)
2.1 Steps in chemical analysis
2.2 Preliminary treatment of sample
Chapter 3: Titrimetry (22 hrs)
3.1 Introduction
 End point and equivalence point
 Direct titration, back titration and back titration with blank determination
 Calculations in titrimetry, Titration curves

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 3.2 Acid-Base titrations
3.2.1 Acid-Base titrations in aqueous media
3.2.2 Acid-Base titrations in non-aqueous media
3.2.3 Applications
3.3 Preciptimetric titrations
3.3.1 Limitations
3.3.2 Solubility product
3.3.3 Factors affecting solubility of precipitate
3.3.4 Indicators
3.3.5 Argentometric titrations
 Mohr’s method
 Volhard’s method
 Fajan’s method
3.3.6 Applications
3.4 Complexometric titrations
3.4.1 Introduction
3.4.2 Basic principles of complexometric analysis
3.4.3 General principles in disodium edetate titrations
3.4.4 Indicators and end point detection
3.4.5 Applications
3.5 Redox titrations
3.5.1 Basic principles of redox titration
3.5.2 Redox indicators
3.5.3 Principles and procedures in different types of redox titration
 Potassium permanganate methods
 Ceric sulfate methods , Iodometric methods
 Bromination methods
 Potassium iodate methods
 Potassium dichromate methods
3.5.4 Applications
Chapter 4: Gravimetry (2hrs)
4.1 Steps in gravimetric analysis
4.2 Selected gravimetric methods
4.3 Applications

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Chapter 5: Limit tests (4 hrs)
5.1 Definition and importance
5.2 Limits on ash values
1.3 Limits on moisture content
 Importance
 Los on drying method
 Azeotropic distillation method
 Karl- Fischer titration method
 Other methods
5.4 Limit tests for some metals -Lead, Arsenic, and Iron
 Limit tests for some non-metals-Chloride , Sulphate
Chapter 6: Electro analytical methods (-- hrs)
 Introduction
 Electrochemical cells
 Various types of Electrodes
 Instrumentation and measurement of cell e.m.f.
 Potentiometry .Principle,Applications in pharmaceutical analysis
 Polarography-Principle,Instrumentation ,Applications in pharmaceutical analysis
Conductometry-Principles,Apparatus and measurement
Applications of direct conductometric methods
Coulometry- Principles,Apparatus and measurement,Applications of coulometric
methods