RAJIV GANDHI PROUDHYOGIKI VISHWAVIDYALAYA M. Pharm (Pharmaceutical Technology) II Semester Course Contents

RAJIV GANDHI PROUDHYOGIKI VISHWAVIDYALAYA

M. Pharm

MPY- 201Pca- ADVANCED PHARMACEUTICAL ANALYSIS –I

(Instrumental and Modern Pharmaceutical Analysis)

1. Separation method : Theory, instrumentation and applications.

i. Supercritical fluid chromatography and extraction

ii. Sizre exclusion chromatography

iii. Ultra performance liquid chromatography

iv. Solid phase micro extraction

v. High performance thin layer chromatography

2. Quantitative optical spectroscopic method:Theory, instrumentation and

applications.

i. Atomic absorption spectroscopic

ii. Inductive coupled plasma atomic emission spectroscopy

iii. Inductive coupled plasma mass spectroscopy

iv. Chemilumience

v. Laser

vi. Photo aquatic spectroscopy

vii. Raman spectroscopy

viii. Optical rotary dispersion

3. Recent advancement in instrumentation and applications if IR, Mass and

NMR with special refernce to FT-IR, GC-MS, LC-MS,FT-NMR, 2D-NMR,

LC-NMR, C-13NMR.Interpretation of IR- NMR and Mass spectra and their

empirical correlation with chemical structure .

4. Solid state analysis

Introduction, analytical methodsto study molecular, particulars and bulk

properties, with special reference to TEM, SEM and Particle size analyzer.

Reference books:

1. Munson J.W., Pharmaceutical Analysis Modern Method part – A

2. Munson J.W., Pharmaceutical Analysis Modern Method part – B

3. Wagner H, Bladt, S., Plant Drug Analysis

4. Frank A. Settle, handbook of Instrumental Techniques for Analytical

Chemistry.

5. Satinder Ahuja and Stephen Scypinski, handbook of Modern

Pharmaceutical Analysis.

6. Mitchell D. Ericson, Analytical Chemistry of PCB’s.

MPY- 202 Pca ADVANCED PHARMACEUTICAL 

ANALYSIS –II

(Quality Control and Quality Assurance of Pharmaceutical)

1. Analytical method validation: Analytical method validation parameter, Procedure,

Cleaning validation, instrumental validation, and personnel validation.

2. Identification and quantitation determination of preservative and antioxidant,

emulsifiers, stablizers in pharmaceutical formulation.

3. Quality controls of containers, closers, caps for pharmaceutical preparation as per

I.P.

4. Quality control of cosmetics products:hair care production, skin care product,

colour cosmetics, body care products, ethnic products, hair setting lotion, eye

shadows.

5. General method of quality control of tablets, capsule and liquid dosage forms,

parentral preparation, ointments and creams, suppositories and controlled release

products.

6. BIOSTATISTICS: Introduction and significance validation of analytical

method normal distribution, degree of freedom, measures of variation standard

deviation, variance standard error, tests for statistical significance-student T test,

chi-square test, correlation of variance and precision accuracy, regression and

correlation for linear and curve system, method of collection of data, graphical

representation of data, mean, mode, median and standard deviation, confidence

level, null hypothesis, analysis of variance, theory of probability, combination and

reaches percentage and proportion and statistical different between proportion.

Analysis of variance, two ways ANOVA and multiple comparison procedure.

Reference books:

1. Indian Pharmacopoeia

2. United State Pharmacopoeia

3. ICH Guidelines.

4. Bolton, S. Pharmaceutical Statistics.

5. Carle Tiori, Validation of Aseptic Pharmaceutical Process.

6. OPPI, Quality Assurance.

7. Lachman, Theory and Practice of Industrial pharmacy

MPY- 203Pca ADVANCED PHARMACEUTICAL ANALYSIS –III

(Biological, Microbiological and Phytopharmaceutical Analysis)

1. Pharmacological method of standardization :

i. Bioassay of pharmacopoeial drugs, methods used in the bioassay of

hormones. Vitamins, cardiac drugs and other pharmacopoeial

Preparations.

ii. Bioassay methods of autocoids

iii. Development of new Bioassay methods for drugs and biochemical

samples.

iv. Biochemical methods of estimating various physiological constants of the

body.

v. Determination of LD50 acute toxicity.

2. Microbiological methods of analysis:

i. Microbiological screening methods for antimicrobial activity, plate

method and serial dilution technique.

ii. Microbiological assay- assay of vitamins and antibiotics with special

reference to drugs official in Indian pharmacopoeia.

iii. Bioassay of some vaccines and antitoxins.

iv. Biological assay fora.

Living contaminant in vaccine

b. Histamine like substance.

c. Heamolysines

d. Heparin, amylase, hyluronidase

3. Analysis of Nutraceutical:

i. General method of analysis of major chemical constituents like

protein, vitamins. Carbohydrate and fat.

ii. Dtermination of physical constant, moisture, solids, crude fibre.

4. Analysis of Phytopharmaceuticals:

i. Method of systematic phytochemical analysis including extraction and

identification of plant constituents using chromatographic techniques.

ii. Quality control of crude drugs: mono and polyherbal formulation by

F.M.O. determination, LOD proximate analysis including ash and

extractive values phytomorphology, crude fibre content, U.V. and

florescence analysis of powdered drugs.

iii. Analysis of official formulation derived from crude drugs including

some ayurvedic preparation.

iv. WHO guidelines, regulatory requirements and patent laws for quality

control of raw materials used in herbal formulations. Standardization

parameter protocol development for herbal products.

Reference books:

1. Wagner H, Bladt S. Plant Drug Analysis.

2. Barton J. Wright, Microbiology Assays.

3. J.H. Burn, D.J.Fonney, S.L.G. Goodwin, Biological Standardization.

4. D.R. Laurence, P.N. bernett, M.J. Boren, Clinical Pharmacology

5. Indian pharmacopoeia.

6. N.Gerhard Vogel, drug Discovery and evaluation.

MPY- 204Pca - ADVANCED PHARMACEUTICAL ANALYSIS –IV

(Applications and Regulatory Guideline for Pharmaceuticals)

1. immunoassay – general principle, heterogeneous and homogenous immuno

system. Production of immunoassay reagent. Immunoassay method

evaluation.

2. Sample preparation and handling : types of samples, sample preparation,

extraction, post extraction derivatization, dilution and matrix matching for

solid, semi solid and liquid organic and inorganic samples.

3. A detailed study of various principles and procedure involved in quanlitative

and quantitative analysis of pharmaceutical preparations using the following

reagent and reaction.

i. oxidative coupling reaction using MBTH (3-methyl-2-

benzothiazolinone hydrazone hydrochloride)

ii. Diazotiazation followed by coupling

iii. Oxidation followed by complexion

iv. Oxidation followed by charge transfer reaction

v. Condensation reaction using the reagents, p-dimethyl amino

benzaldehyde

(PDAB), p-dimethyl amino cinnamaldehyde (PDAC),

foilns reagent and Gibbs reagent, folin ciocalthechu

reagent.

4. Good Laboratory Practice: overview and regulatory guidelines for GLP

5. An overview of kinetic concept. Stability prediction and calculation protocol.

Regulatory requirement, experimental design and interpretation of data for

Degradation and impurity analysis of pharmaceutical drug candidate and

dosage forms as per ICH and USFDA guidelines.

6. Bioanalytical method development for pharmaceutical drug candidate and

dosage forms as per ICH and USFDA guidelines and their application to

clinical studies.

Reference books:

1. Indian Phaarmacopoeia

2. ICH Guidelines.

3. USFDA guidelines

4. Cartensem, Drug stability, principles and practices.

5. Convors. Amiden and Stella, Chemical Stability of Pharmaceuticals.

6. Wagner, Principles of Clinical Pharmacokinetics.

7. Rowland and Tozer, Clinical Pharmacokinetics.

8. Ritschel. Handbook of basic Pharmacokinetics.

9. Gibaldi, Biopharmaceutics and clinical Pharmaceutics.

10. Frank A. Settle, Handbook of Instrumental techniques for Analytical

chemistry..