Question bank from Michael dong:

Chapter 1 Explain the following terms by giving example. 1. Void volume 2. Retention time. & relative retention time 3. Theoretical plate no 4. Reproducibility 5. Response factor 6. Tailing factor and fronting factor Regulatory requirement: 1. Explain the terms 1. Precision 2. Accuracy 3. Resolution 4. Linearity 5. Limit of detection 6. Limit of quantification 7. Ruggedness 8. Robustness 9. System suitability test 2. Define four categories of analysis as described in USP. Give example of each category of analysis. You are asked to develop analytical method for dissolution test of tablet. Which category this analysis will fall into? Which are the parameters you will consider for validation of method that you have developed? 3. Give details about DQ, IQ, OQ, PQ for HPLC system. What factors are tested for pump and detector?

Question bank from Snyder

Chapter 1 1. 2. 3. 4. 5. What are the steps for method development? Why sample pre-treatment is required? What are different parameters for improving separation? How repeatability of experiment is checked? What is a rugged method?

Chapter 2 1. 2. 3. 4. 5. 6. 7. 8. Explain the concept of resolution. Explain the ways in which resolution can be measured. What is minimum resolution? Explain the effect of selectivity, efficiency and retention on resolution. State the effect of solvent strength on resolution. Explain the importance of column plate number with necessary equations. Explain the importance of selection of sample size in HPLC analysis. Below given is an e.g. of a pesticide sample explain the effects of column length, flowrate and particle size packing on resolution, run-time and pressure.

Chapter 3 1) What are the different types of detectors used in HPLC Analysis? Give example of one compound where each of these detectors are used as per USP. [08] 2) Describe the significance of Signal/Noise ratio for better assay precision.[08] OR Systematic approach for improving UV detection sensitivity [05] 3) With neat and labelled diagrams describe principle and working of any 2 detectors in HPLC.[08] 4) Write a note on peak identification & peak purity.[06] 5) Characteristics of Universal HPLC detectors.[04] 6) Give the sensitivity of the following detectors:[01] - Diode array, - Refractive index, - Evaporative light scattering & - Fluorescence detector. 7) The diode array UV detector alone can be used for peak purity studies of compound? Justify. [01] 8) Limitations of Refractive index detector. [01] 9) Oxidative electrochemical detection is more commonly used than reductive electrochemical detection. Why? [01] 10) Which are the compound types generally not sensed by the Electrochemical detector? [01] 11) Brief note on ionization methods used in Mass Spectrometer. [08] Question bank upto first sessional -----------------------------------------------------------------------------------------------------------------