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Seat No.: Enrolment No.
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GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER- VII - EXAMINATION - WINTER -2020
Subject Code: 2270014 Date: 16/01/2021
Subject Name: Instrumental and Process Validation
Time: 10:30AM To 12:30PM Total Marks: 54
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Instructions:
- Attempt any THREE questions from Q-1 to Q-6.
- Q.7 is compulsory to attempt.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
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Q.1 (a) Discuss methods of precipitation of protein from biological fluid 06
(b) Describe Operational qualification and Performance qualification for Autoclave 05
(c) What are the types of automated analytical systems 05
Q.2 (a) Discuss steps for mobile phase optimization in HPLC 06
(b) What is hyphenated technique? write note on LC-MS. 05
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(c) Explain different types of columns use in GC 05
Q.3 (a) Discuss scope, types and advantages of validation 06
(b) Give steps for validation of Fluidized Bed Drier. 05
(c) Explain briefly validation master plan 05
Q.4 (a) Discuss Column resolution, Selectivity factor and Capacity factor in Liquid 06 chromatography.
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(b) Describe validation of HPLC system. 05
(c) Explain injector and guard columns in HPLC. 05
Q.5 (a) Discuss Design qualification and Installation qualification of equipment. 06
(b) Explain validation of Tablet - manufacturing process. 05
(c) What are objectives and stages of cleaning validation? 05
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Q.6 (a) Enlist detectors used in GC. Discuss any two. 06
(b) Discuss derivatization in GC 05
(c) Discuss steps involved in qualification of Dry powder Mixer 05
Q.7 (a) Write a note on HPTLC. 06
OR
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(a) Discuss troubleshooting in LC/MS 06
OR
(a) Describe selection of detector in HPLC 06
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