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1 Course Title Course Code APPLIED PHARMACEUTICAL ANALYSIS QA202 Lecture : 04 Course Credit Practical : 04 Tutorial : 00 Total : 08 Course Objectives To explain the students about application of various concepts of analysis for determination of various category of ingredients presents in different types of materials and formulations and applications of various analytical techniques in preformulation analysis, analysis of solid dosage form, injectables and cosmetics. Detailed Syllabus - Theory Sr. No. Name of Chapter & Details Hours Allotted Section-I 1 Application of analytical methods to product obtained through genetic engineering, Amino acid sequence analysis, Tryptic maping, ion exchange amino acid analysis, isoelectric focusing etc Analytical determination of following elements: (a) Sodium (b) Potassium 06
2 (c) Calcium (d) Halogens (e) Phosphorus (f) Sulphur 3 Solid state analysis of drug substance including related substances, and impurities present in drugs and their effect on drug stability and therapeutic action Applications of various analytical techniques in preformulation analysis and its importance Compendial testing 03 Section-II 6 Analysis of solid oral dosage form 04 7 Analysis of injectable dosage form 04 8 Automated analysis 04 9 Compendial methods for evaluation of crude drug and herbal formulation Quality control of radio pharmaceuticals and radio chemical method in analysis Analysis of drugs from biological samples including, selection of biological sample, extraction of drugs by various methods as LLE, SPE and Membrane filtration. 05
3 12 Analysis of cosmetics PAT, Real time release testing 02 Applied Pharmaceutical Analysis-(Practical) 1. Assay of Ibuprofen Tablet I.P., Tolbutamide Tablet I.P., Calcium Lactate and Ferrous Fumerate I.P. 2. Determination of water in Sorbitol, Sodium Citrate & Ampicillin. 3. Determination of total chloride in Thiamine Chloride Hydrochloride. 4. Quality control tests for tablets, capsules, injections, ointments and suppositories. 5. Detection and determination of preservatives, antioxidants and colouring materials in pharmaceuticals. 6. Determination of related substances in Albendazole, Amiloride, Metronidazole, Betamethazone, Carbamazepine, Diclofenac, Ephedrine, Ibuprofen, Paracetamol, Eucalyptus oil, Phenylbarbitone and Sulphafurazone, Rifampicin as per I.P. 7. Determination of active constituents in crude drugs. E.G. Caffiene from tea powder, curcumin from curcuma longa, quinine from cinchona bark etc. 8. Quality control tests for some herbal formulations. 9. Quality control tests for some cosmetics. 10. To study the dissolution-time profile of conventional dosage form (tablet) of Metformin Hydrochloride. 11. To study the dissolution-time profile of sustain release tablet of Metformin Hydrochloride. Test require for tablet dosage form as per IP,BP,USP 12. To perform test as per monograph of Paracetamol 13. IP 96 Introduction to standard to capsules and ointment as per IP,BP,USP 14. Comparative evaluation of different brands of Ibuprofen tablets by dissolution test and assay as per IP 96.
4 Instructional Method and Pedagogy: Lectures will be conducted with the aid of multi-media projector, black board, OHP etc. Assignments based on course content will be given to the students at the end of each unit/topic and will be evaluated at regular interval. Surprise tests/quizzes/seminar/tutorials will be conducted. The course includes language practices such as Group Discussion, Interviews etc to develop the communication skills of the students. Students Learning Outcomes: As the outcome, the students will be able to apply various concepts of analysis for determination of various category of ingredients presents in different types of materials and formulations. Students will be able to apply various analytical techniques in preformulation analysis, analysis of solid dosage form, injectables and cosmetics. Text Books: 1. Vogel s text book of quantitative chemical analysis-jeffery J Bassett, J. Mendham, R.C. Denney, 5 th edition, ELBS, Text book of pharmaceutical analysis- K A Connors, 3 rd edition, John Wiley & Sons, S. Ahuja, Modern Pharmaceutical Analysis Reference Books: 1. Harry G Brittain, Spectroscopy of Pharmaceutical Solids, Drugs and Pharm Sci. Series, Vol. 160, Taylor and Francis, 2006 N.Y. 2. The quantitative analysis of drugs D C carratt, 3 rd edition, CBS publishers, New delhi,
5 Lena Ohannesian and Anthony J. Streeter, Hand Book of Pharmaceutical Analysis, Pharm Sci. series, Vol. 117, Maarcel Dekker Inc., N.Y 4. Peptide and Protein Drug Analysis, by Reid, (Marcel Dekker). 5. Classification of cosmetics raw materials and adjuncts IS 3958 of Indian Standards Institution (BIS). 6. Cosmetic and toilet goods methods of sampling IS 3958 of Indian Standards Institution (BIS). 7. Methods of sampling and test for various cosmetics as laid down by Indian Standard Institution (BIS). 8. Indian Pharmacopoeia,Vol. I and Vol. II The Controller of Publications; New Delhi, Govt. of India, 9. The International Pharmacopoeia Vol 1,2,3,4, 3rd Edition General methods of analysis and quality specifications for pharmaceutical substances, excipients, dosage forms. 10. Quality Assurance of Pharmaceuticals A compendium of guidelines and related materials Vol.1 and Vol.2, WHO, (1999) 11. Basic tests for pharmaceutical substances WHO (1988) 12. Basic tests for pharmaceutical dosage forms WHO (1991) 13. Phytochemical Methods by J. B. Harborne 14. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy) 15. The analysis of drugs in biological fluids- Joseph chamberlain, 2 nd Edition, CRC press, London. 16. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience. Additional Resources Various research journals, magazines and internet sources
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Course Title Course Code PHARMACEUTICAL VALIDATION AND QUALITY MANAGEMENT SYSTEM QA204 Lecture : 04 Course Credit Practical : 04 Tutorial : 00 Total : 08 Course Objective To explain the students about
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