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Jawaharlal nehru technological university anantapur

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
Course Structure and Syllabus for M. Pharm-Pharmaceutical Analysis & Quality
Assurance for affiliated Pharmacy Colleges 2009-10
I SEMESTER
Bio-Statistics, Intellectual Property Rights& Electrometric methods and spectral analysis Modern Pharmaceutical Analysis Practical– 1 Electrometric and chromatographic methods of II SEMESTER
Analytical method development and validation Analytical method development and validation- Practical Evaluation of Dosage forms-Practicals (III & IV Semesters)
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year I semester
MODERN PHARMACEUTICAL ANALYSIS

1. UV-VISIBLE SPECTROSCOPY: Brief review of electromagnetic spectrum, UV-
Visual range, energy, wavelength and color relationships. Interaction of electromagnetic radiation (UV-visible) with matter and its effects. Chromophores and their interactions with E.M.R. Absorption spectra of organic compounds and complexes illustrating the phenomenon and its utilization in qualitative and quantitative studies of drugs. Shifts and their interpretation (including solvent effects). Empirical correlation of structure with absorption phenomena (Woodward’s rules etc) Quantitative estimations, Modern instrumentation.
2. a) INFRARED SPECTROSCOPY: Nature of Infra-red radiation. Interaction of I.R
radiation with I.R molecules and effects on bonds. Molecular Infrared Spectra.
Brief outline of classical I.R instrumentation and practical details of obtaining
spectra, including sample preparation for spectroscopy, quantitative interpretation
of I.R spectroscopy including FT-IR, ATR.
b) OPTICAL ROTATORY DISPERSION: Fundamental principles of ORD,
cotton effect curves, their characteristics and interpretation. Octant rule and its application with examples. Circular dichroism and its relation to ORD. 3. NMR SPECTROSCOPY: Fundamental principles of NMR (Magnetic properties of
nuclei, applied field and precession; absorption and transition; frequency). Chemical shifts concept: Isotopic nuclei, Reference standards: Proton magnetic spectra, their characteristics, presentation terms used in describing spectra and their interpretation (Signal No., Position and Intensity). Brief outline of instrumental arrangements and some practical details. Signal multiplicity phenomenon in high resolution PMR. Spin-spin coupling. Application of Signal split and coupling constant data to interpretation of spectra. De-coupling and shift reagent methods. Brief outline of principles of FT-NMR with reference to 13CNMR. Spin-spin and spin-lattice relaxation phenomenon. Free induction decay (FID) proton noise de-coupling signal, average time domain and frequency domain signals nuclear overhauser enhancement 13CNMR spectra, their presentation; characteristics, interpretation, examples and applications. Brief indication of application of magnetic resonance spectral data of other nuclei by modern NMR instruments. Introduction to 2-D NMR techniques.
4. MASS SPECTROSCOPY: Basic principles and brief outline of instrumentation. Ion
formation and types; molecular ion, Meta stable ions, fragmentation processes. Fragmentation patterns and fragmentation characteristics in relation to parent structure and functional groups. Relative abundances of isotopes and their contribution to characteristic peaks. Mass spectrum, its characteristics, presentation and interpretation. Chemical ionization Mass Spectroscopy. GC-MS, other recent advances in MS. Fast atom bombardment mass spectrometry. LC-MS, LC MS-MS. 5. CHROMATOGRAPHIC TECHNIQUES: Classification of chromatographic
methods based on mechanism of separation. Column chromatography, column materials, merits and demerits. Paper chromatography; techniques and applications. Thin Layer Chromatography, comparison to paper chromatography and HPLC, adsorbents for TLC. Preparation techniques, mobile phase selection, reversed phase TLC, High performance TLC detection methods, quantitative methods in TLC. Programmed multiple development techniques.
6. GAS CHROMATOGRAPHY: Instrumentation packed and open tubular column,
Column efficiency parameters, the Vandeemeter equation, Resolution, liquid stationary phase, derivatization methods of GC including acylation, perfloro acylation, alkylation and esterification. Detectors: FID, ECD, TCD, NPDA. Critical comparison of sensitivity, selectivity and field of applications of these detectors. Examples of GC applications in pharmaceutical analysis. 7. LIQUID CHROMATOGRAPHY: Comparison of GC and HPLC, instrumentation
in HPLC, analytical, preparative and micro bore columns, normal and reversed phase packing materials, reverse phase HPLC, Column selection, Mobile phase selection, Efficiency parameters, resolution, detectors in HPLC refractive index, photometric and electrochemical. Comparison of sensitivity, selectivity and field of applications of these detectors. HPTLC-instrumentation and applications.
8. ELECTROPHORESIS: Moving boundary electrophoresis, Zone electrophoresis,
Iontophoresis, PAGE, Isotacophoresis and applications in pharmacy.
X-ray Diffraction methods: introduction, generation of X-rays, elementary
crystallography, Miller Indices, X-rays diffraction, Bragg’s law, X-ray powder
diffraction, X-ray powder diffractometer, obtaining and interpretation of X-ray
powder diffraction data. Principle, instrumentation and application of the following:
Differential Scanning Colorimetry (DSC), DTA &TGA in analysis of
pharmaceuticals.
REFERENCES:
1. Instrumental methods of chemical analysis by Chatwal. K, Anand, 5th edition. 2. Vogel’s text book of quantitative chemical analysis by G.H.Jeffery, J.Bassett, 3. Instrumental methods of analysis by Willard, Merit, Dean, Settle. 4. Organic spectroscopy by Y.R.Sharma. 5. Spectrometric identification of organic compounds by Silverstein, Webster. 6. Spectroscopy by B.K.Sharma 7. Fundamentals of analytical chemistry by Skoog 8. Instrumental methods of analysis by Skoog. 9. Text book of pharmaceutical analysis by S.Ravishankar. 10. Organic spectroscopy by William kemp 11. Spectroscopic methods in Organic chemistry by Dudley William and Ian JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year I semester

BIO-STATISTICS, INTELLECTUAL PROPERTY RIGHTS &
REGULATORY AFFAIRS
BIO-STATISTICS
1. An introduction to statistics and biostatistics-collection and organization of data,
graphical, pictorial presentation of data, measures of central tendency and dispersion, sampling techniques, sample size, Coefficient of variation, mean error, relative error, precision and accuracy 2. Tests of significance: Testing hypotheses – Principles and applications of Z, t, F–
ratio and chi-square tests in pharmaceutical and medical research. Non-parametric tests: sign test, Wilcoxon signed rank test, Wilcoxon rank sum test, Kruskal Wallis test, run test and median tests.
3. Design of Experiments: Principles of randomization, replication and local
control; CRD, RBD, LSD – their applications and analysis of data; Factorial Experiments – Principles and applications; Probit analysis: Dose – effect relationships, calculation of LD50, ED50. 4. Statistical quality control : Meaning and uses , Construction of X, R, P, ηp and
INTELLECTUAL PROPERTY RIGHTS & REGULATORY AFFAIRS

1. Patents and Intellectual Property Rights (IPR): Definition, scope, objectives, sources of patent information, patent processing and application. Patents, Copyrights, Trademarks, Salient features, international and regional agreements. 2. GATT & WTO: GATT – Historical perspective, objectives, fundamental principles, impact on developing countries. WTO – objectives, scope, functions, structure, status, membership and withdrawal, dispute settlement, impact on globalization, India – task and challenges, trade related aspects (TRIPS). 3. Regulatory Affairs : Indian context – requirements and guidelines of GMP, understanding of Drugs and Cosmetics Act 1940 and Rules 1945 with reference to Schedule N ,U & Y. 4. a).Related Quality Systems: Objectives and guidelines of USFDA, WHO and
b).Documentation: Types related to pharmaceutical industry, protocols,
harmonizing formulations, development for global filings, ANDA, NDA, CTD, dealing with post – approval changes – SUPAC, handling and maintenance including electronic documentation. REFERENCES:

1. KS Negi ‘Biostatistics’ ,AITB Publishers, Delhi. 2. Irfan Alikhan ‘Fundamentals of Biostatistics’, Ukaaz Publications 3. Khan and Khanum ‘Biostatistics for Pharmacy’, Ukaaz Publications 4. J.E, Demuth ‘Basic statistics and Pharmaceutical applications’ ,Mercel & Dekker. 5. Applied statistics by S.C.Gupta & V.K.Kapoor 6. Fundamentals of mathematical statistics by S.C.Gupta & V.K.Kapoor 7. Good Manufacturing Practices for Pharmaceuticals, S.H. Wiling, Vol. 78, Marcel 8. Protection of Industrial Property rights, P. Das & Gokul Das 9. Law and Drugs, Law Publications. S.N. Katju 10. Original Laws Published By Govt. of India 11. Laws of drugs in India, Hussain 12. New Drug Approval Process, R.A.Guarino,Vol 100, Marcel Decker, NY 13. fda.org, wipo.int, patentlawlinks.com, hc-sc.gc.ca, ich.org, cder.org JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year I semester

ELECTROMETRIC METHODS AND SPECTRAL ANALYSIS
Principles, instrumentation and applications of the following spectral and
electrometric methods of analysis.
1. UV – visible & IR spectrophotometry
2. NMR Spectrometry
3. ESR Spectrometry
4. Atomic absorption Spectroscopy
5. Plasma emission Spectroscopy
6. Atomic force Microscopy & Photon co-relation spectroscopy
7. Spectrofluorometry
8. Electrometric Methods :
Conductometry, High frequency titrations, potentiometry, REFERENCES:
1. R.M. Silversterin and G.C. Bassler, Spectrometric Identification of analysis 2. Sittle: Handbook of Instrumental Techniques for Analytical Chemistry 3. Robert D Brown, Introduction to Instrumental Analysis. 4. Skoogadwest – Principles of Instrumental analysis. JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year I semester

CHROMOTOGRAPHIC METHODS OF ANALYSIS
Introduction, Principle , Method of preparation and different types of stationary
& mobile phases, Instrumentation, Interpretations, Data analysis and its
applications of the following


1.
Paper Chromatography & Thin layer chromatography
2. Column chromatography & Gas chromatography
5. Exclusion chromatography & Super critical fluid chromatography
6. Vapour phase chromatography & Affinity chromatography
7. Ion – exchange chromatography & Centrifugal partition chromatography
8. LCMS & GCMS
REFERENCES
1. R.M. Silverstein, ‘spectrometric identification of organic compounds’. 2. B.K. Sharma ‘Instrumental Methods of Chemical Analysis’, Goel Publications 3. Chatwal and Anand ‘Instrumental Methods of Chemical Analysis’, Himalaya 4. H. Kaur ‘Instrumental Methods of Chemical Analysis’, Pragati Prakashan 5. P.D. Sethi ‘Qualitative Analysis of Drugs and Pharmaceuticals 6. I.M. Kolthaf ‘Quantitative Chemical Analysis’ JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Chemistry
I year I semester

MODERN PHARMACEUTICAL ANALYSIS - PRACTICAL
1. Simultaneous estimation of Paracetamol and Ibuprofen, Rifampicin and 2. UV-Visible spectrum scanning of certain organic compounds- absorption and co-relation of structures, comparisons. Ex: a. Chloramphenicol 3. Effect of pH and solvent on UV spectrum of certain drugs. 4. Two dimensional paper chromatography and TLC. 5. Gradient elution and other techniques in column chromatography. 6. Separation by electrophoresis.(PAGE and agarose Gel electrophoresis) 7. Experiments based on HPLC and GC. 8. IR, NMR and Mass spectroscopy of compound each. 9. DSC/XRD curves of a sample and mixture to understand polymorphism. 10. Determination of insulin / any other hormones by ELISA method. JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year I semester

ELELCTROMETRIC & CHROMATOGRAPHIC METHODS OF ANALYSIS
PRACTICAL
Preparation of Mobile Phase, Standard Solution, Sample Solution, Internal Standard for Acetaminophen, Caffeine and Codeine Phosphate Tablets as per USP. Test for Identification by using HPLC – For any Compendial Drug Test for Assay by using HPLC – For any Compendial Drug Test for Uniformity of Dosage Units by using HPLC – For any Tablets / Capsules as per USP. Test for Dissolution by using Dissolution Apparatus and HPLC – For any Test for Residual Solvents by using GC – For any Compendial Drug Determination of Alcohol Content by using GC Test for Assay by using GC - For any Compendial Drug Test for Identification by using HPTLC – For any Compendial Drug Test for Assay by using HPTLC – For any Compendial Drug Test for Impurity Profile by using HPTLC – For any Compendial Drug Test for Degradation compounds by using TLC – For Acetaminophen as Determination of  max of different drugs and preparation of calibration curve. (Ephedrine Hydrochloride, Sulphanilamide, etc.). Estimation of drugs by UV Spectrophotometry Mimesulide tablets, Paracetamol, Pyridoxine, Pheniramine maleate, 3. To study the quenching effect of Quinine sulphate by Fluorimetry. 4. Interpretation of IR spectra of Polystyrene, Salicylic acid, etc. 5. Assay of drugs by IR Spectrophotometry by baseline technique. 6. Interpretation of NMR spectra of pure drugs. 7. Identification of different functional groups by IR (amino group, alcoholic group amide, ester, acid group etc) 9. Determination of Iodine values of natural oils. Olive oil, Peanut oil etc. 10. Assay of total zinc in Insulin zinc suspension by Atomic Absorption 11. Assay of Sodium, Potassium and Calcium in blood serum and water by 12. Assay of some inorganic agents by Flame Emission Spectroscopy Sodium chloride, Potassium citrate, Magnesium acetate. 13. Assay of drugs by Potentiometric method of analysis. Cimetidine, Nitrazepam, Clonidine etc. 14. Assay of Procainamide hydrochloride by Amperometric titration method. 15. Study of different fragments of Mass Spectra of different pure drugs. JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

QUALITY ASSURANCE OF PHARMACEUTICALS
1. a. Concepts of Total Quality Management (TQM) and Good Manufacturing Practices (GMP) b. Organization and personnel – Responsibilities and Training. 2. Good Laboratory Practices (GLP): Routine controls, Instruments, Protocols, Non- Clinical Testing, Controls on Animal House, Applications of Computers in Quality Control Laboratory. 3. Finished product Release: Quality Review, Quality Audits, Batch Release 4 Warehousing: Good ware housing practices Materials Management 5 Documentation related to Product Development, Standard operating procedures, standard test procedures, cleaning methods, quality control documents, batch release document, distribution records, complaints and recalls records, retention of records. 6 Regulatory Affairs - Drugs and Cosmetic Act, DPCO, Intellectual Property right 7 New Drug Development and Approval Process: Investigational New Drugs (IND), New Drug Applications (NDA), Supplemental New Drug Application (SNDA). 8 a. ICH requirements for registration of Pharmaceuticals b. WHO certification scheme on the quality of pharmaceutical products.
References

1) Quality Assurance of Pharmaceuticals (A compendium of guidelines and selected materials) Vol I & II (Pharma Book Syndicate, Book Street, Hyd) 2) Basic Texts for Pharmaceutical substances WHO (1988, 1991) 3) A guide to Total quality management K. Maitra and S.K. Ghosh 4) Good Manufacturing Practice (GMP) by Mehra 6) ISO 9000 and Total Quality Management by S.K. Ghosh. 7) Packaging Drugs and Pharmaceuticals W.A. Jenkins & K. R. Osborn. 8) The Drug and Cosmetic Act 1940 by Vijay Malik 9) The International Pharmacopoeia, Vol. 1-4 JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

ADVANCED PHARMACEUTICAL ANALYSIS
Principles and procedures involved in quantitative determination of the following
functional groups
A. Hydroxy
General methods for the estimation of the following
A. Proteins
Principles and procedures involved in the use of the following reagents in Pharmaceutical Analysis A. 3- Methyl 1-2- benzothiozoline hydrozone (MBTH) Thermal Methods of Analysis: Theory of Thermal gravimetric Analysis ( TGA), Differential thermal Analysis (DTA), Differential Scanning calorimetry (DSC) and Thermal Mechanical Analysis (TMA) Principles and procedures involved in the following physicochemical methods including the assays of official drugs mentioned in IP. Principles and procedures involved in the following physicochemical methods
including the assays of official drugs mentioned in IP.
a) Diazotization titration b) Potentiometer titration c) Conduct metric titration
a. Radiometric analysis: radio activity, radioisotopes and Pharmaceutical
Applications of radiopharmaceuticals
b. Radio Immune Assay: Principle, Procedures and applications.
c. ELISA Test
Preparation drug samples for analysis: Pharmaceutical samples, fundamental theories controlling preparation techniques, specific sample preparation techniques. REFERENCES

1) Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
2) Pharmaceutical Chemistry by Becket and Stanlake
3) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi
4) Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
5) Theory and Practice of Industrial Pharmacy by Lieberman and Lachman
6) Indian Pharmacopoeia 1996
7) Instrumental Methods of Chemical Analysis by B.K. Sharma
8) A Text Book of Pharmaceutical Analysis by Kerrenth A. Conners
9) Journals like Indian Drugs, IJPS etc.
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION
Concept of Analytical Method development, validation and calibration of various analytical instruments for drug analysis Development of analytical Methods and validation of the following techniques
A. UV-Visible spectrophotometer
Development of analytical Methods and validation of the following techniques
A. HPLC
A detailed study on related substances and impurities present in drugs and their effect on drug stability and therapeutic action. ICH guidelines for impurity and related substances determination in the drugs Validation Methods for the following
A. Analytical Procedures
C. Air handling equipment and facilities in zone Validation of sterilization methods and equipment, Dry heat sterilizations, Auto
cleaving membrane filtration.

Validation Methods for the following
a. Water supplies
b. Water supply systems: Deionised , distilled, purified, Demineralised and water for injections Accuracy, Precision and Linearity, Sources of Errors, use of significant figures and their correct usage, Intraday and interlay analysis. System suitability and ruggedness of the method


REFERENCES
1) Pharmaceutical Process Validation by Ira R. Berry and Robert A. Nash
2) Quality assurance and TQM for analytical laboratories by M. Parkany, The
Royal Society of Chemistry
3) SOP Guidelines by D. H. Shah
4) GMP, by M.L. Mehra
5) A Guide to Total Quality Management by Kaushik Maitra and Sadhan K.Ghosh
6) Microbiological Assays by Barton J. Wright
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

EVALUATION OF DOSAGE FORMS
1. Detailed study of the principles and procedures involved in various physicochemical methods of analysis of Pharmaceutical dosage forms belong to the following classes 2. A detailed study on the principles and procedures involved in the determination of the dosage forms of the following group of drugs A. Adrenergic B. Anti-malarial C. Steroids 3. Official methods of determination for the mentioned below pharmaceutical dosage 4. Various in process Quality Control tests carried on the following of Dosage Forms 5. A detailed study on the biological evaluation of the following dosage forms
6. Microbiological evaluation of the following dosage forms
7. Quality control of crude drugs: Proximate analysis including ash and extractive values, crude fibre content, UV and Florescence analysis of powdered drugs. 8. a. Detection of common adulterants and insects infestation in whole and powdered drugs.
b. WHO guidelines for the quality control raw materials
c. Brief study of quality control of plant products and their High throughput

REFERENCES

1) Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
2) Microbiological Assays by Barton J. Wright
3) Pharmaceutical Chemistry by Becket and Stanlake
4) Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi
5) Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
6) Theory and Practice of Industrial Pharmacy by Lieberman and Lachman
7) Indian Pharmacopoeia 1996
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION PRACTICALS
Comparison of different methods available for various dosage forms with the official methods mentioned in IP, BP, USP etc. Method of Determination by colourimetry is compared with the official IP method for its accuracy of the following drugs JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY ANANTAPUR
M.Pharm Pharmaceutical Analysis & Quality Assurance
I year II semester

EVALUATION OF DOSAGE FORMS -PRACTICAL
3. Assay of trimethoprim and sulphamethoxazole 6. Assay of Acetyl Salicylic acid tablets. Mini Projects:

The mini projects can be taken up as industrial visit/training and report submission.
A suitable project shall be carried out in the college.
The Project Work:
Separate guidelines will be issued

Source: http://www.svcop.in/syllabus/4.%20MPharm%20-%20PA%20&%20QA%20Syllabus.pdf

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