GUJARAT TECHNOLOGICAL UNIVERSITY

Bachelor of Pharmacy
Subject Code: BP701TP
SEMESTER: VII
Subject Name: Instrumental Methods of Analysis

Scope: This subject deals with the application of instrumental methods in qualitative and quantitative
analysis of drugs. This subject is designed to impart a fundamental knowledge on the principles and
instrumentation of spectroscopic and chromatographic technique. This also emphasizes on theoretical and
practical knowledge on modern analytical instruments that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to

1. Understand the interaction of matter with electromagnetic radiations and its applications in drug
analysis.
2. Understand the chromatographic separation and analysis of drugs
3. Perform quantitative & qualitative analysis of drugs using various analytical instruments.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 4 6 80 20 80 20

Sr No Topics %
weightage
1. UV Visible spectroscopy 10
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent
effect on absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells,
detectors- Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon
Photodiode.
Applications - Spectrophotometric titrations, Single component and multi
component analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and
external conversions, factors affecting fluorescence, quenching, instrumentation
and applications
2. IR spectroscopy 10
Introduction, fundamental modes of vibrations in poly atomic molecules, sample
handling, factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay
cell, Bolometer, Thermocouple, Thermister, Pyroelectric detector and
applications
Flame Photometry-Principle, interferences, instrumentation and applications
Atomic absorption spectroscopy- Principle, interferences, instrumentation and
Applications
Nepheloturbidometry- Principle, instrumentation and applications
3. Introduction to chromatography 10
Adsorption and partition column chromatography-Methodology,
advantages, disadvantages and applications
Thin layer chromatography- Introduction, Principle, Methodology, Rf values,
advantages, disadvantages and applications
Paper chromatography-Introduction, methodology, development techniques,
advantages, disadvantages and applications

Page 1 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP701TP
Electrophoresis– Introduction, factors affecting electrophoretic mobility,
Techniques of paper, gel, capillary electrophoresis, applications
Gas chromatography - Introduction, theory, instrumentation, derivatization, 8
4. temperature programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC)-Introduction, theory,
instrumentation, advantages and applications
5. Ion exchange chromatography- Introduction, classification, ion exchange 7
resins, properties, mechanism of ion exchange process, factors affecting ion
exchange, methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and
applications

Practical
1. Determination of absorption maxima and effect of solvents on absorption maxima of organic
compounds
2. Estimation of dextrose by colorimetry
3. Estimation of sulfanilamide by colorimetry
4. Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5. Assay of paracetamol by UV- Spectrophotometry
6. Estimation of quinine sulfate by fluorimetry
7. Study of quenching of fluorescence
8. Determination of sodium by flame photometry
9. Determination of potassium by flame photometry
10. Determination of chlorides and sulphates by nephelo turbidometry
11. Separation of amino acids by paper chromatography
12. Separation of sugars by thin layer chromatography
13. Separation of plant pigments by column chromatography
14. Demonstration experiment on HPLC
15. Demonstration experiment on Gas Chromatography

Recommended Books (Latest Editions)

1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy byWilliam Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein

Page 2 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP702TT
SEMESTER: VII
Subject Name: Industrial Pharmacy II

Scope: This course is designed to impart fundamental knowledge on pharmaceutical product

development and translation from laboratory to market.

Objectives: Upon completion of the course the student shall be able to

1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 0 4 80 20 0 0

Sr No Topics %
weightage
1. Pilot plant scale up techniques: General considerations – including 10
significance of personnel requirements, space requirements, raw materials, Pilot
plant scale up considerations for solids, liquid orals, semi solids and relevant
documentation, SUPAC guidelines, Introduction to platform technology
2. Technology development and transfer: WHO guidelines for Technology 10
Transfer(TT): Terminology, Technology transfer protocol, Quality risk
management, Transfer from R & D to production (Process, packaging and
cleaning), Granularity of TT Process (API, excipients, finished products,
packaging materials) Documentation, Premises and equipments, qualification
and validation, quality control, analytical method transfer, Approved regulatory
bodies and agencies, Commercialization - practical aspects and
problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL,
TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing,
MoUs, legal issues
3. Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, 10
Regulatory authorities, Role of Regulatory affairs department, Responsibility of
Regulatory Affairs Professionals
Regulatory requirements for drug approval: Drug Development Teams,
Non-Clinical Drug Development, Pharmacology, Drug Metabolism and
Toxicology, General considerations of Investigational New Drug (IND)
Application, Investigator’s Brochure (IB) and New Drug Application (NDA),
Clinical research / BE studies, Clinical Research Protocols, Biostatistics in
Pharmaceutical Product Development, Data Presentation for FDA Submissions,
Management of Clinical Studies.
Quality management systems: Quality management & Certifications: Concept 8
4. of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma
concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000
series of quality systems standards, ISO 14000, NABL, GLP
5. Indian Regulatory Requirements: Central Drug Standard Control 7
Organization (CDSCO) and State Licensing Authority: Organization,
Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory
requirements and approval procedures for New Drugs.

Page 1 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP704TT
SEMESTER: VII
Subject Name: NOVEL DRUG DELIVERY SYSTEMS

Scope: This subject is designed to impart basic knowledge on the area of novel drug delivery systems.

Objectives: Upon completion of the course the student shall be able to

1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development of Novel
drug delivery systems, their formulation and evaluation.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 4 0 80 20 0 0

Sr No Topics %
weightage
1. Controlled drug delivery systems: Introduction, terminology/definitions and 10
rationale, advantages, disadvantages, selection of drug candidates.Approaches
to design controlled release formulations based on diffusion, dissolution and ion
exchange principles. Physicochemical and biological properties of drugs
relevant to controlled release formulations
Polymers: Introduction, classification, properties, advantages and application
of polymers in formulation of controlled release drug delivery systems.
2. Microencapsulation: Definition, advantages and disadvantages, microspheres 10
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion /
mucoadhesion, concepts, advantages and disadvantages, transmucosal
permeability and formulation considerations of buccal delivery systems
Implantable Drug Delivery Systems:Introduction, advantages and
disadvantages, concept of implantsand osmotic pump
3. Transdermal Drug Delivery Systems: Introduction, Permeation through skin, 10
factors affecting permeation, permeation enhancers, basic components of
TDDS, formulation approaches
Gastroretentive drug delivery systems: Introduction, advantages,
disadvantages, approaches for GRDDS – Floating, high density systems,
inflatable and gastroadhesive systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary
routes of drug delivery, Formulation of Inhalers (dry powder and metered dose),
nasal sprays, nebulizers
Targeted drug Delivery: Concepts and approaches advantages and 8
4. disadvantages, introduction to liposomes, niosomes, nanoparticles, monoclonal
antibodies and their applications
5. Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods 7
to overcome –Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and
disadvantages, development of intra uterine devices (IUDs) and applications

Page 1 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP706TT
SEMESTER: VII
Subject Name: Quality Assurance

Scope: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like
cGMP, QC tests, documentation, quality certifications and regulatory affairs.

Objectives: Upon completion of the course the student shall be able to

1. understand the cGMP aspects in a pharmaceutical industry
2. appreciate the importance of documentation
3. understand the scope of quality certifications applicable to pharmaceutical industries
4. understand the responsibilities of QA & QC departments.

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme

Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 0 4 80 20 0 0

Sr No Topics %
weightage
1. Quality Assurance and Quality Management concepts: Definition and 10
concept of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief
overview of QSEM, with special emphasis on Q-series guidelines, ICH stability
testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program,
tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures
2. Organization and personnel: Personnel responsibilities, training, hygiene and 10
personal records.
Premises: Design, construction and plant layout, maintenance, sanitation,
environmental control, utilities and maintenance of sterile areas, control of
contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
maintenance, purchase specifications and maintenance of stores for raw
materials.
3. Quality Control: Quality control test for containers, rubber closures and 10
secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel,
Facilities, Equipment, Testing Facilities Operation, Test and Control Articles,
Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports,
Disqualification of Testing Facilities
Complaints: Complaints and evaluation of complaints, Handling of return 8
4. good, recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record,
Master Formula Record, SOP, Quality audit, Quality Review and Quality
documentation, Reports and documents, distribution records
5. Calibration and Validation: Introduction, definition and general principles of 7
calibration, qualification and validation, importance and scope of validation,

Page 1 of 2
w.e.f. AY 2017-18
 GUJARAT TECHNOLOGICAL UNIVERSITY
Bachelor of Pharmacy
Subject Code: BP706TT
types of validation, validation master plan. Calibration of pH meter,
Qualification of UV-Visible spectrophotometer, General principles of
Analytical method Validation.
Warehousing: Good warehousing practice, materials management

Recommended Books (Latest Editions)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, SandyWeinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol
IWHO Publications.
4. A guide to Total QualityManagement- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma.
6. ISO 9000 and Total QualityManagement – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality
specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines

Page 2 of 2
w.e.f. AY 2017-18