Sunday, 22 July 2012

Shivaji university, Revised Syllabus for M. Pharmacy Pharmaceutical Analysis Syllabus to be introduced & implemented from June, 2012 onwards.


Accredited By NAAC
(2009)



M.Pharm. Course Structure Pharmaceutical Analysis
Scheme of Teaching Scheme of Examination
Semester Subject Hours / week Theory Practical
Code Title of Paper
Lecture Practical Hours Marks Hours Marks
Total

MAT Modern Analytical Techniques (Compulsory) 03 06 03 100 06 100 200
APA-I Advanced Pharmaceutical Analysis – I 03 06 03 100 06 100 200
AIT Analytical Instrumentation and Technology 02 01(Tutorial)
03 100 -- -- 100
ELE-I Elective – I 02 01(Tutorial)
03 100 -- -- 100
Seminar * One per student A+ / A / B / C -- -- --
Research Work -- 09 -- -- -- --

Sem – I
Group discussion 03 (01+01+01) Monitoring and record keeping --
RMB Research Methodology & Biostastics
( l )
03 06 03 100 06 100 200
APA-II Advanced Pharmaceutical Analysis – II 03 06 03 100 06 100 200
FBCA Food, Biologicals and Cosmetic Analysis 02 01(Tutorial)
03 100 -- -- 100
ELE-II Elective-II 02 01(Tutorial)
03 100 -- -- 100
Seminar * One per student A+ / A / B / C -- -- --
Research Work -- 09 -- -- -- -- --

Sem – II
Group discussion 03 (01+01+01) Monitoring and record keeping --
Colloquium * One per student A+ / A / B / C -- -- --
Sem – III & THESIS Research, Dissertation and viva voce -- 50 -- -- -- 200 200
Sem – IV
GRAND TOTAL 1400

* The seminar / colloquium shall carry 50 marks


Syllabus for M. Pharm. (Pharmaceutical Analysis)
Modern Analytical Techniques 3 hr/week Theory
Sr. No. Name of Topic Hours Marks
1. Biostatistics and Computer Application:
Student’s t-test, F test, Chi-square test, Analysis of variance
(ANOVA), correlation and regression analysis, Factor
analysis , Time series analysis, Multidimensional scaling,
applications of computers related to pharmaceutical
analysis. 3 10-15


2. Sample Preparation for Analysis:
Different techniques of sample preparation from
body fluids, tissue extracts, cell culture extracts
and phyto-chemical extracts. 5 10-15 


3. Structural Elucidation by Spectroscopic Methods:
UV-Visible, IR, NMR and Mass with examples. 5 15-20

4. Applications of DSC and XRD:
Analysis of raw material (APIs and excipients), packaging
material and finished products. 4 10-15


5. Reference Standards:
Introduction, preparation, types, storage, record keeping and
validation. 5 10-15


6. ESR Spectroscopy:
Introduction, calibration, validation and application (in
brief).
Circular Dicorism and ORD:
Introduction, calibration, validation and application (in
brief). 5 10-15


7. Particle Size Analysis:
Introduction, significance, methods used in particle
size analysis.
Gel Permeation Chromatography (GPC):
Introduction, instrumentation (Stationary phases and
Detectors) and its application ( particle size analysis).
4 15-20

8. Immunochemical Techniques:
Particle methods like Precipitation, light scattering, label
method, ELISA, Immuno- precipitation, Radio immune
assays and Radio-labeling. 5 20-25



Reference Books
1. Introduction To Biostatistics & Computer Science, Mr. Y. I. Shah Dr. A. R. Paradkar,
Mr. Y. I. Shah, Mr. M. G. Dhayagude
2. Pharmaceutical statistics using SAS: a practical Guide, Ralph B. D'Agostino
3. Introduction to Pharmaceutical Calculations, Judith A. Rees
4. Text book of Practical Pharmaceutical chemistry, Vol. I & II, AH Beckett & Stenlake.
5. Practical Method Development, Snyder, L. R., Kirkland, J. J. and Glajch, J. L.
6. Principles of Instrumental Analysis, Skoog.
7. Textbook of Practical Biotechnology, C.R. Kokare.
8. Organic Spectroscopy, William Kemp
9. Physical Pharmacy – Martin, Swarbrick and Commarata
10.Physical Chemistry – Bahl and Tuli
11.Spectrometric identification of organic compounds, Silverstein RM, Webstar FX.
12.I. P., B.P. and U.S.P.
13.Instrumental Methods of Analysis, Chatwal & Anand,
14.A Textbook of pharmaceutical analysis, K. A. Connors.
15.Pharmaceutical Analysis, Ashutosh Kar.
16.Instrumental and Chemical Analysis, B.K. Sharma.


Modern Analytical Techniques 3Hrs/ Week Practicals
1. Chemical Tests for Identification of Alkaloids, Glycosides and steroids in extracts.
2. Preparation and chemical characterization of cosmetics like talcum powder, lipsticks,
deodorant and cream.
3. To carry out microbiological assay of antibiotics by Cup Plate and turbidimetric
method
4. UV spectroscopic analysis of two component formulation by simultaneous equation
and differential spectroscopic method.
5. Visible spectroscopic method development involving transition metal and ion pair
complex.
6. Proposing structures of compounds at least three on analysis of UV, IR, NMR and
mass spectra.
7. DSC and XRD spectra analysis to study drug-excipient analysis.
8. Particle size analysis by calibrated Nephalo-turbidimetry.
9. ED50 and LD50 Estimation and probit analysis

Reference Books
1. Text book of Practical Pharmaceutical chemistry, Vol. I & II, AH Beckett &
Stenlake.
2. Textbook of Pharmacognosy, Kokate C. K. Purohit A. P. and Gokhale S. B.
3. Pharmacognosy and Phytochemistry, Vol. I & II, V.D.Rangari.
4. Natural products Chemistry Practical Manuals, A.A.Siddiqui.
5. Indian Pharmacopoeia.
6. Spectrometric identification of organic compounds, Silverstein RM, Webstar FX.
7. Harry’s cosmetology, J. B. Wilkinson and R. J. Moore.
8. Textbook of Practical Biotechnology, C.R. Kokare.
9. Research Articles on method development in Journals
10. Physical Pharmacy – Martin, Swarbrick and Commarata
11. Physical Chemistry – Bahl and Tuli

Advanced Pharmaceutical Analysis-I
Theory 3Hrs/ Week
Sr. No. Name of Topic Hours Marks
1. UV-Visible Spectroscopy:
Introduction, calibration, validation and application (in
brief), Woodward-Fisher rule. 5 15-20


2. IR-Spectroscopy:
Introduction, calibration, validation and application (in
brief) of IR and FT-IR spectroscopy. 6 15-20

3. NMR Spectroscopy:
Introduction, calibration, validation and application (in
brief) of P-NMR and C-NMR. 5 15-20

4. Mass Spectroscopy:
Introduction, calibration, validation and application (in
brief). 4 15-20


5. Atomic Absorption and Atomic Emission spectroscopy:
Introduction, calibration, validation and application. 4 10-15

6. Thermal Analysis:
Theory and applications of Thermo gravimetric Analysis,
Differential Thermal Analysis, Differential Scanning
Calorimeter. 6 15-20


7. Named Reactions, their mechanism and application in drug
analysis: Grignard, Perkin, Darzen, Mannich and Merrifield
solid phase synthesis. 3 10-15

8. Karl- Fischer Titration:
Introduction, reagents instrumentation, calibration,
validation and application (in brief) of Karl- Fischer
Titration. 3 05-10


Reference Books
1. Instrumental and Chemical Analysis, B.K. Sharma.
2. Organic spectroscopy, William Kemp
3. UV-Visible Sectrophotometry in Pharmaceutical Analysis, Sándor Görög
4. Handbook of Instrumental Techniques for Analytical Chemistry, Settle.
5. Text Book of Pharmaceutical analysis, Vol. I & II, Kasture, Wadodkar, Mahadik and
More.
6. A Textbook of pharmaceutical analysis, K. A. Connors.
7. Principles of Instrumental Analysis, Skoog.
8. Instrumental methods of analysis, Hobart. H. Willard.
9. Instrumental Methods of Analysis, Chatwal & Anand,
10. Text book of Practical Pharmaceutical chemistry, Vol. I & II, AH Beckett & Stenlake.
11. Capillary Electrophoresis: Instrumentation and Operation, Wim Kok.
12. Pharmaceutical Analysis, Ashutosh Kar.
13. Spectrometric identification of organic compounds, Silverstein RM, Webstar FX.
14. Instrumental methods of chemical analysis, Ewing, GW.

Advanced Pharmaceutical Analysis-I
Practicals 3 Hrs/ Week
Carry out analysis of at least two samples under each experiment.

1. Estimation of partition and distribution coefficient of drugs by electrochemical methods.
Determination of pKa & pKb of acidic and basic drugs by electrochemical methods.
2. In-vitro protein binding assay of some drugs.
3. To formulate and perform IPQC tests for solid, liquid, ointment dosage form as per IP,
BP and USP.
4. Separation of serum protein, amino acid mixture and saccharides by electrophoresis.
5. Biochemical analysis using Auto-analyzer.

Reference Books
1. Physical Pharmacy – Martin, Swarbrick and Commarata
2. Practical Pharmaceutics (Physical Pharmacy), H. N. More, Ashok Hajare
3. Theory & Practice of Industrial Pharmacy, Lachman Liebermann & Kanig
4. I. P., B.P. and U.S.P.
5. Textbook of Practical Biotechnology, C.R. Kokare.
6. Capillary Electrophoresis: Instrumentation and Operation, Wim Kok.
7. Physical Chemistry – Bahl and Tuli

Advanced Pharmaceutical Analysis-II
Theory 3 Hrs/Week
Sr. No. Name of Topic Hours Marks

1.HPLC and UPLC:
Introduction, principle, chemistry of stationary phases,
stationary and mobile phase selection, retention parameters
and their correlation, calibration, validation and
applications. 6 20-25

2. Methods for Sensitivity and Selectivity Enhancement in
HPLC:
Pre-column Derivatization, Post-column Derivatization, Ion
Suppression and Ion Pair chromatography. 5 10-15


3. HPTLC:
Introduction, principle, Instrumentation, calibration,
validation and applications. 5 20-25

4. Hyphenated Techniques:
GC-MS, LC-MS, LC-MS-MS, LC-NMR and their
application in structural elucidation and quantitative analysis
of complex mixtures. 5 10-15

5. Chromatographic Method Development:
Objective, principle, steps involved in resolution and peak
shape optimization, techniques for method development,
sample preparation and HPLC assay of multi-component
formulations containing hydrochlorothiazide official in USP
with reference to choice of stationary and mobile phase. 4 10-25

6. Validation:
Guidelines for analytical and bio-analytical methods
validation as per ICH, AOAC and USFDA guidelines. 3 10-15

7. Reference Standards:
Introduction, preparation, types, storage, record keeping and
validation. USP-NF reference standards, compendial
reference standards, non- compendial reference standards
and their applications in analysis. 4 10-15

8. Electrophoresis:
Introduction stationary phases, mobile phases and
application of paper, starch, agarose gel, acrylamide and
Capillary electrophoresis. 4 10-15

Reference Books
1. Instrumental and Chemical Analysis, B.K. Sharma.
2. Practical Method Development, Snyder, L. R., Kirkland, J. J. & Glajch, J. L
3. Spectrometric identification of organic compounds, Silverstein RM, Webstar FX.
4. Instrumental methods of chemical analysis, Ewing, GW.
5. European Pharmacopoeia
6. ICH Q2A. (1994). Text on Validation of Analytical Procedures.
7. ICH Q2B. (1996). Validation of Analytical Procedures: Methodology.
8. USFDA guidelines for Bio-analytical method validation.
9. Bioavailabity and Bioequivalence in Pharmaceutical Technology, Pal, P.K. and
Ganesan, M.
10. A Textbook of pharmaceutical analysis, K. A. Connors.
11. Instrumental methods of analysis, Hobart. H. Willard.
12. Instrumental Methods of Analysis, Chatwal & Anand,
13. An Introduction to HPLC for Pharmaceutical Analysis, Oona McPolin
14. Analytical Chemistry by open learning series.
15. Introduction to High Performance Liquid chromatography, R. J. Hamilton.

Advanced Pharmaceutical Analysis-II
Practical 3 Hrs/ Week

1. Fluorometric assay of pharmaceuticals.
2. Study of simple chemical changes on λ max and absorbtivity of chemical compounds and
drugs.
3. Development and validation of UV-Visible spectrophotometric method for multicomponent
pharmaceutical formulations.
4. Identification and separation of drugs by paper, thin layer and column chromatography.
5. Structural Elucidation using UV-Visible, IR, NMR and Mass spectroscopy.
6. Estimation of drugs from body fluids.
7. Identification and separation of drugs and their related products.

Reference Books
1. Analytical Chemistry by Open Learning: fluorescence and phosphorescence, Rendell
and David.
2. Organic spectroscopy, William Kemp.
3. Instrumental Methods of Analysis, Chatwal & Anand,
4. Spectrometric identification of organic compounds, Silverstein RM, Webstar FX.
5. Text book of Practical Pharmaceutical chemistry, Vol. I & II, AH Beckett & Stenlake.
6. ICH Q2A. (1994). Text on Validation of Analytical Procedures.
7. ICH Q2B. (1996). Validation of Analytical Procedures: Methodology.
8. Research articles on analytical method development in Journals.


Analytical Instrumentation and Technology
Theory 2 Hrs/Week
Sr. No. Name of Topic Hours Marks
1. pH and Conductivity and dissolved component analysis:
Instrumentation and engineering of Conductivity meters and
pH meters, dissolved oxygen, hydrogen analyzers – sodium
analyzer, silica analyzer and sampling systems
4 20-25

2. Gas analyzers: Instrumentation and engineering of all
detectors. Thermal conductivity types, CO monitors, NOX
analyzers, oxygen analyzer, paramagnetic type, detectors
and sampling systems. H2S analyzer system and sampling,
Industrial analyzer circuits, Theory and problems on Beer
and Lambert laws.
4 15-20

3. UV, VIS Spectrophotometers – Instrumentation and
engineering of single beam, double beam and other variants,
Instrumentation associated with the above
Spectrophotometers, Light sources, optics and detectors.
4 20-25

4. Flame emission and atomic absorption
spectrophotometer – Instrumentation and engineering of
atomic absorption and flame emission spectrophotometer,
sources for Flame Photometers and online calorific value
measurements.
3 10-15

5.NMR and Mass Spectrophotometry: Instrumentation and
engineering of NMR Spectrophotometer and mass
spectrophotometers,
3 10-25

6. Radio Activity Measurement: Instrumentation and
engineering of Nuclear radiation detectors, Ionization
chamber, GM Counter, Proportional Counter, Solid state
detectors.
2 10-15

7. ESR spectrophotometry: Instrumentation and engineering
of ESR spectrophotometry 2 10-15

8. FT-IR Spectrometer - Instrumentations and engineering of
IR Spectrophotometers. 2 05-10

Reference Books
1. Handbook of Analytical Instruments – by Khandpur. TMH
2. Instrumental Methods of Analysis – by Willard H.H., Merrit L.L., Dean J.A.. and
Seattle F.L., CBS Publishing and Distributors, 6/e, 1995.
3. Instrument Technology – by Jones B.E., Butterworth Scientific Publ., London, 1987.
4. Mechanical and Industrial Measurements – by Jain R.K., Khanna Publishing, New
Delhi, 2/e, 1992.
5. Principles of Instrumental Analysis – by Skoog D.A. and West D.M., Holt Sounder
Publication, Philadelphia, 1985.
6. Instrumental Analysis – by Mann C.K., Vickerks T.J. & Gullick W.H., Harper and
Row Publishers, New York, 1974.
7. Http://jntu.ac.in/dap/syl.html

Research Methodology & Biostatistics
Theory 3 Hrs/Week
Sr. No. Name of Topic Hours Marks

1. Introduction to research: Defining Research, Scientific
Enquiry, Hypothesis, Scientific Method, Types of Research,
Applications of research, Research Process and steps in it,
deductive and inductive reasoning.
5 15-20

2. Intellectual property and related regulations: Indian
Patent Act 1970, its amendments, concepts of IPR.
INDA/NDA/ANDA filing. Introduction to Patent Search.
OECD guidelines for chemical testing pertaining to use as
drug, related substances, excipients, toxicity, etc. WHO
guidelines for standardization of raw material and finished
products including herbal products.
8 20-30

3. Formulating a research problem: Sources,
Considerations, Steps in formulation of a problem and
formulation of objectives. Definition of variables –
Concepts, indicators and variables, Types of variables,
Types of measurement scales. Constructing the Hypothesis-
Null(Research) and alternative, one-tailed and two-tailed,
Hypothesis testing, errors in testing. Problem Solving –
Types, Process and Approaches – Logical, Soft System and
Creative; Creative problem solving process, Development of
Creativity, Group Problem Solving Techniques for Idea
Generation – Brain storming and Delphi Method.
7 20-25

4. Research Design: Design of Experiments: Objectives,
strategies, Factorial experimental design, Guidelines for
design of experiments. Simple Comparative Experiments:
Basic statistical concepts, random variable, sample mean and
variance, degrees of freedom, standard normal distribution,
statistical hypothesis, Two sample t-test, P-value, Confidence
Intervals and Paired comparisons. Control and noise factors
and parameter design, signal to noise ratio, types, parameter
design strategy, tolerance design and robust design.
7 20-25

5. Research Proposal: Review of literature, Preamble, the
problem, objectives, hypothesis to be tested, study design,
setup, measurement procedures, analysis of data,
organization of report; Displaying data- tables, graphs and
charts.
4 10-15

6. Research Report and thesis: Writing a research report-
Developing an outline, Key elements- Objective,
Introduction, Design or Rationale of work, Experimental
Methods, Procedures, Measurements, Results, Discussion,
Conclusion, Referencing and various formats for reference
writing of books and research papers, Report Writing-
Prewriting considerations, Thesis writing.
5 15-20

References:
1. http://www.patentoffice.nic.in/
2. http://www.ignou.ac.in/schools/sos/ipr_web2/IPR_Awareness/Web%20pages/UNIT%
204.pdf
3. http://en.wikipedia.org/wiki/
4. www.pci.nic.in/contents.htm
5. www.oecd.org/dataoecd/9/11/33663321.pdf
6. http://www.fda.gov/fdac/special/testtubetopatient/studies.html
7. http//www.fda.gov/cder/about/smallbiz/faq
8. Available at: http//www.fda.gov/cder/consumerinfo
9. http//www.fda.gov/cder/consumerinfo/generic_info/generics_question_brochure
10. Ranjit Kumar, (2006), Research Methodology- A Step-By-Step Guide for Beginners,
(Pearson Education, Delhi) ISBN: 81-317-0496-3
11. Trochim, William M.K., (2003), 2/e, Research Methods, (Biztantra, Dreamtech Press,
New Delhi), ISBN: 81-7722-372-0
12. Montgomery, Douglas C. (2007), 5/e, Design & Analysis of Experiments, (Wiley
India)
13. Montgomery, Douglas C., & Runger, George C. (2007), 3/e, Applied Statistics &
Probability for Engineers, (Wiley, India)
14. Kothari, C.K., (2004), 2/e, Research Methodology- Methods and Techniques, (New
Age International, New Delhi)
15. Ross, Philip J. (1996), 2/e, Taguchi Techniques for Quality Engineering, (McGraw
Hill, NY)
16. Besterfield, Dale H. (2005), 3/e, Total Quality Management, (Pearson Education, New
Delhi)
17. Krishnaswamy, K. N., Sivakumar, Appa Iyer and Mathirajan, M. (2006), Management
Research Methodology: Integration of Principles, Methods and Techniques (Pearson
Education, New Delhi).
18. Aluru, Srinivas, ed. Handbook of Computational Molecular Biology. Chapman &
Hall/Crc, 2006. ISBN 1584884061.
19. Baxevanis, A.D. and Ouellette, B.F.F., eds., Bioinformatics: A Practical Guide to the
Analysis of Genes and Proteins, third edition. Wiley, 2005. ISBN 0-471-47878.
20. Central Drugs Standard Control Organization http://cdsco.nic.in/


Research Methodology & Biostatistics
Practical 3 Hrs/ Week

1. Patent search reports.
2. INDA/NDA/ANDA filing draft preparations.
3. Research design experiments.
4. Research proposal writing.
5. Research report writing.

Food, Biologicals and Cosmetic Analysis
Theory 2 Hrs/Week
Sr. No. Name of Topic Hours Marks

1. Analysis of food:
Analytical methods for food constituents like carbohydrates,
fats and proteins with special emphasis on determination of
moisture, ash, elemental analysis, trace component analysis,
physical constants and toxicological testing ( NELA and
FDA).
4 15-20

2.Analytical Methods for milk products:
Methods for analysis of milk, milk constituents and milk
products like ice products, milk powder, butter, cheese
including adulterants and contaminants of milk.
4 15-20

3. Analysis of fermentation products like wine, spirits, beer
and vinegar. 2 10-15

4. Analysis of Cosmetics:
Analysis of raw materials used in cosmetic industry
including quality control tests for the following products
such as baby care, skin care products, dental products,
personal hygiene preparations, lips sticks, hair products,
antiperspirants, deodorant, sunscreen skin creams.
CTFA guidelines for cosmetic stability, in relation to
ingredients and finished products.
4 15-20

5. Safety legislation to cosmetic products and different
toxicity tests for cosmetics. 2 10-15

6. Nutraceuticals:
Concept, use and testing as per USP-NF, guidelines for raw
material and final products of various nutra-ceuticals.
3 10-15

7. Analytical Techniques used in Food, Cosmetic and
Nutra-ceuticals analysis:
Principle and applications of Near IR, SP Radio-immune
assay, Raman spectroscopy, X ray fluorescence, Particle
size analysis, ICP in Analysis of Food, Cosmetic and Nutraceuticals.
3 15-20

8. Herbal Medicines: Standard requirement of herbal
medicines, traditional and folk remedies, preparation and
their quality, safety and efficacy assessment with respect to
WHO and FDA guidelines
2 10-15

Reference Books
1. The Chemical Analysis of Foods and Food Products, Morris B. Jacobs.
2. Hand book of Analysis and Quality Controll for Fruit and Vegetables Products,
S.Ranganna
3. Handbook of cosmetic sciences and technology, J. Knowlton and S. Rearce.
4. Modern Cosmetics, E. G. Thomssen.
5. Harry’s cosmetology, J. B. Wilkinson and R. J. Moore.
6. The Chemical Analysis of Food, David Pearson
7. Introduction To Chemical Analysis of Food, S.Nielsen.
8. Official Methods of Analysis, AOAC International.
9. Analysis of Food Constituents, Multon.
********************

Related Posts Plugin for WordPress, Blogger...
IF U DIDN'T GOT , WHAT UR LUKING FOR REQUEST US BY CONTACTING US CLICK ON CONTACT US!