I/II M.PHARMACY (1 st Semester)

Size: px

Start display at page:

Download "I/II M.PHARMACY (1 st Semester)"

Doreen Douglas
6 years ago
Views:

1 I/II M.PHARMACY (1 st Semester) 1.1 T : ADVANCED INSTRUMENTAL METHODS OF ANALYSIS 1. UV-VISUAL SPECTROSCOPY : Brief review of electromagnetic spectrum, UV-Visual range, energy-wavelength-color relationship. Interaction of electromagnetic radiation (UV-Vis) and matter and its effects. Chromophores and their interaction with Electromagnetic Radiation. Absorption spectra of organic compounds and complexes illustrating the phenomenor and its utilization in qualitative and quantitative analysis of drugs. Shifts and their Interpretation (including solvent effects) 2. INFRA-RED SPECTROSCOPY : Nature of Infra-red radiation. Interaction of IR. Radiation with organic molecules and effects on bonds. Brief outline of classical I.R. instrumentation and the interpretation of spectra, including sample preparation for spectroscopy. Qualitative interpretation of I.R. spectra. Quantitative methods useful in drug analysis. 3. NUCLEAR MAGNETIC RESONANCE 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 Maganetic spectra, their characteristics, presentation, terms used in describing spectra and their interpretation (Signal no. Position, intensity). Brief outline of instrumental arrangements and some practical details. Signal multiplicity phenomena in high resolution PMR Spin spin coupling. Application of Signal Sprit and coupling constant data to interpretation of spectra. Decoupling and shift reagent methods. Brief outline of principles of FT-NMR with reference to 13 CNMR; Spin-spin and spin-lattice relaxation phenomena. Free induction decay (FID) proton noise decoupling signal averaging time domain and frequency domain signals nuclear overhauser enhancement; CNMR spectra, their presentation, characteristics, interpretation examples and application in drug analysis. :: 01 ::

2 4. MASS SPECTROMETRY : Basic principles and brief outline of instrumentation. Ion formation and types, molecular ion, meta stable ions, fragmentation processes, fragmentation patterns and fragment characteristics in relation to parent structure and functional groups. Relative abundances of isotopes and their contribution to characteristics peaks. Mass spectrum, its characteristics, presentation and interpretation. Chemical ionization mass spectrometry, GC-MS other recent advances in MS, FAST ATOM BOMBARDMENT MASS spectroscopy. Application of mass spectrometry in the analysis of drug. 5. GAS CHROMATOGRAPHY : Instrumentation packed and open tubular column, column efficiency parameters, the Van Deemeter equation, Resolution, liquid stationary phases, Derivatisation methods of GC including acylation, perfluoroacylation, alkylation and esterification. Detectors; FID, ECD, TCD, NPD. A critical comparison of sensitivity, selectivity and field of application of these detectors. Examples of GC applications in Pharmaceutical Analysis. 6. LIQUID CHROMATOGRAPHY : Comparison of GC and HPLC, instrumentation in HPLC, analytical, preparative and micropore columns, normal and reversed-phase packing materials, Reversephases 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. 7. X-RAY DIFFRACTION AND DSC, DTA METHODS : Introduction, Generation of X-Rays, Elementary crystallography; miller Indices, X- ray, diffraction Bragg s law, X-ray powder diffraction, X-ray powder diffractometer, obtaining and interpretation of X-ray powder diffraction data. Applications of XRD, DSC and DTA in the characterization of Pharmaceutical solids. 8. RADIO IMMUNO ASSAY METHODS : :: 02 ::

3 I/II M.PHARMACY (1 st Semester) 1.1 P : ADVANCED INSTRUMENTAL METHODS OF ANALYSIS-(PRACTICALS) PRACTICALS BASED ON THEORY 1.1T Advanced Instrumental Methods of Analysis (AIMA) Recommended Books 1. Instrumental Methods of Analysis-Willard, Merrit, Dean et.al 2. A Text Book of Pharmaceutical Analysis (Vol. 1 & 2) - Roger E.Schirmer 3. Methods of Drug Analysis -Gaerian & Grabowski 4. A Text Book of Pharmaceutical Analysis - K.A.Connors 5. Practical Pharmaceutical Chemistry (Vol. 1 & 2) - Beckette & Stenlake 6. Pharmaceutical Analysis - P.Parimoo 7. Spectroscopy - Silverstein 8. Organic Spectroscopy - William Kemp 9. Pharmaceutical Analysis - Modern Methods by J.W.Munson, (Marcel Dekker) :: 03 ::

4 I/II M.PHARMACY (1 st Semester) 1.2 T : ADVANCED PHARMACEUTICAL ANALYSIS 1. A detailed study of principles and physico-chemical techniques involved in the analysis of pharmaceutical formulations like i) Antibiotics (ii) Steroid Hormones (iii) Vitamins (iv) NSAIDs v) Sulfa drugs. 2. A detailed study of principles and physico-chemical techniques involved in the analysis of pharmaceutical formulations like i) Anti-cancer drugs (ii) Anti-HIV drugs (iii) Diuretics (iv) Analgesics 3. General methods of quality control of the following as per Indian Pharmacopoeia. i) Tablets (ii) Capsules (iii) Liquid orals (iv) Parenterals 4. Quality control of crude drugs : Ash value, extraction values, preparation, characterization, usage, storage and records. 5. Reference standards-source, preparation, characterization, usage, storage and records. 1.2 P PRACTICALS : BASED ON THEORY Recommended Books : 1. Pharmaceutical Analysis - T.Higuchi 2. Indian Pharmacopoeia (Government of India) 3. Text book of Pharmacognosy - C.K.Kokate :: 04 ::

5 I/II M.PHARMACY (1 st Semester) 1.3. T : BIOLOGICAL ASSAYS, IMMUNOLOGICAL ASSAYS AND TOXICITY STUDIES a) Biological Methods of Analysis : Introduction and a detailed study of the following biological assays as per Indian Pharmacopoeia Heparin Sodium 2. Hyaluronidase 3. Chorionic gonadotropnin 4. Insulin 5. Oxytocin 6. Vasopressin 7. Diphtheria Antitoxin 8. Gas-gangrene antitoxin i. Oedematiens ii. Perfringens iii. Speticum 9. Rabies antiserum 10. Tetanus antitoxin 11. Petrusis Vaccine 12. Thyroid Vaccine b) Immunological Methods of Analysis : Introduction and a detailed study of Radio Immuno Assay (RIA) and Enzyme linked Immunosorbent Assay (ELISA). Microbiological Assay of Vitamins and Antibiotics. c) Toxicity Studies : 1. A study of the following as per Indian Pharmacopoeia Test for Histamine like substances 3. Test for pyrogens 4. Test for undue Toxicity RECOMMENDED BOOKS : 1. Indian Pharmacopoeia (Vol. 1 & 2) published by Ministry of Health & Family Welfare, Government of India. :: 05 ::

6 I/II M.PHARMACY (2 nd SEMESTER) 2.1.T ADVANCED PHARMACEUTICAL ANALYTICAL TECHNIQUES AND SPECIAL ANALYTICAL REAGENTS IN PHARMACEUTICAL ANALYSIS Part - I : Theory, instrumentation and applications of the following Special Techniques in Analuysis : a) Super Fluid Critical Chromatography b) Gel permeation Chromatography c) Affinity Chromatography d) Electrophoresis Part - II : Principles and procedures involved in using the following Chromogenic reagents in Pharmaceutical Analysis : a) Folin-Ciocalteu reagent (FC reagent) b) 3-Methyl-2-Benzothiazolinone hydrazone hydrochloride (MBTH) reagent c) P-N-Methylamino phenol Sulphate (Metol) d) N-1-Naphthyl Ethylenediamine dihydrochloride (Bratton-Marshell agents) e) Emmerie-Engel reagent f) P-dimethylaminobenzaldehyde (PDBA) and P- dimethylaminocinnamaldehyde (PDAC) g) 1, 2-Naphthaquinone-4-sulfonate sodium (NQS) h) 2, 4, 6-tripyridyl-S-triazine (TPTZ) i) Dyes (for extractive spectrophotometry) j) Ninhydrin reagent :: 06 ::

7 I/II M.PHARMACY (2 nd SEMESTER) 2.1.P ADVANCED PHARMACEUTICAL ANALYTICAL TECHNIQUES AND SPECIAL ANALYTICAL REAGENTS IN PHARMACEUTICAL ANALYSIS PRACTICALS : BASED ON THEORY RECOMMENDED BOOKS & JOURNALS : 1. Instrumental Methods of Analysis, Willard, Dean and Merrit et al 2. A Text book of pharmaceutical Analysis (Vols. 1 & 2) - Roger E Schnmor 3. Methods of Drug Analysis - Gaerian & Grbowski 4. A Text Book of Pharmaceutical Analysis - K A Connors 5. Practical Pharmaceutical Chemistry (Vols. 1 & 2) - Beckette & Stenlake. 6. Pharmaceutical Analysis - P.Parimoo 7. Pharmaceutical Analysis - Kodern Methods by J W Munson (Marcel Decker) 8. Indian Drugs (Journal Published by IDMA) 9. Journal of Industrial and Scientific and Inddustrial Research (Journal Published by CSIR) 10. Journal of Pharmaceutical and Biomedical Analysis 11. Analysis (International Journal) 12. Analyst (International Journal) 13. Pharma Zie (International Journal) :: 07 ::

8 I/II M.PHARMACY (2 nd SEMESTER) 2.2.T QUALITY ASSURANCE & QUALITY CONTROL (QA & QC) 1. Concepts and Philosophy of TQM, GLP, SOP, ICH, ISO Organization and Personnel responsibilities, training, hygiene and records. 3. In process quality controls on various dosage forms (sterile and non sterile) 4. Packaging and Labeling Controls : Line clearance, reconciliation of labels; cartons and other packaging material; types and tests assuring quality of glass. Types of plastics used, permeation, leaching, sorption, chemical reactions, biological tests, modification of plastics by drugs; Different types of closures and closure liners; film wrapper; Blister packs, Bubble packs, shrink handling; foil/plastic pouches, bottle seals, tape seals, breakable seals and sealed tubes; Quality control of packaging material and filling equipment. 5. Warehousing and Good warchousing practices 6. Distribution and Distribution of records, Handling of returned goods, Recovered materials and Reprocessing. 7. Complaints and Recalls, Evaluation of complaints, Recall procedures, Related records and documents. 8. Regulatory aspects of Pharmaceuticals and Bulk drug Manufacturing, Regulation of drugs and pharmaceuticals. 9. Certification and licensing procedures, WHO and NABL certification accreditation. 10. Stability testing of formulation and shelf life prediction. 2.2.P QUALITY ASSURANCE & QUALITY CONTROL (QA & QC) PRACTICALS : BASED ON THEORY REFERENCES : 1. Quality assurance and quality management in pharmaceutical industry - Y.Anjaneyulu (Pharma Book Syndicate) 2. Quality Assurance Guide - Vol. 1 & 2, Organization of Pharmaceutical Products of India. :: 08 ::

9 I/II M.PHARMACY (2 nd SEMESTER) 2.3.T VALIDATION AND DOCUMENTATION 1. Validation methods of a) Equipment b) Processing Techniques including mixing, granulation, drying compression, filtration and filling. c) Methods of equipment for dry heat sterilization, autoclaving and membrane filtration. d) Air handling equipment and facilities in zones e) Water supply systems, de-ionized and distilled water and water for injection. 2. Calibration of Analytical Instruments - Validation of Systems and validation of analytical procedures (as per ICH and Pharmacopoeia) 3. Sampling techniques, collection and classification of data, common tendency, precision and accuracy, probability theory, correlation and regression, Test for significance, t-test, F-test, chi-square test and analysis of variance (ANOVA) 4. Data Generation and Storage 5. Finished products release, Quality Review, Quality audits, Batch release and documentation. RECOMMENDED BOOKS FOR 2.2 T AND 2.3 T 1. Quality Assurance of pharmaceuticals (A compendium of guidelines and selected materials (Vol. 1 & 2, Pharma Book Syndicate, Book street, Hyderabad) 2. Basic tests for pharmaceutical substances by WHO (1988, 1991) 3. A guide to total quality management - K.Mitra and SK Ghosh 4. Good manufacturing practice (GMP) - Mehra 5. How to practice GMP - PP Sharrma 6. ISO 9000 and total Quality Management - SK Ghosh. 7. Packaging drugs and Pharmaceuticals - WA Jenkins & KR Osborn 8. The drug and cosmetic Act, Vijay Malik 9. European Pharmacopoeia (Vol. 1 to 4) 10. Analytical validation iii & tech, Ching Chang Chaw. :: 09 ::

I/II M.PHARMACY (1 st Semester)

I/II M.PHARMACY (1 st Semester) 1.1 T : ADVANCED INSTRUMENTAL METHODS OF ANALYSIS 1. UV-VISUAL SPECTROSCOPY : Brief review of electromagnetic spectrum, UV-Visual range, energy-wavelength-color relationship. Interaction of electromagnetic