No

Module Name

Validation of Analytical Methods Practice

1

Code of Subjects

P10A02.0509

2

Study load

1(0-1) credits

Contact hour per semester: 13

Total workload : 13

3

Semester

5

4

Precondition

P10A.0306

5

Competence

After attending this lecture, students are able to explain and design method validation in developing a reliable modern analytical method, and analyze the validation parameters set in accordance with the requirements of ICH, USP and guidelines for industry

6

Elements of Competency

MKK

7

Type Competency

Main competence

8

Syllabus

In this course participants will learn about the basis for validation of sample analysis methods in the field of pharmacy, validation characteristics and types of analytical procedures; aspects in the development of analytical methods which include the importance of measuring error, standardization of analytical methods (external standards, internal standards, standard additions), optimization of analytical methods, validation of analytical methods, estimation of measurement uncertainty, qualification and verification, Factors that affect the accuracy of analysis results: processing experimental data with correct statistics, standard materials (reference), the influence of analysis conditions, and sampling, as well as validation protocols.

9

Attribute Soft Skill

Ethics, awareness, and discipline

10

Learning methods

Lab. practice, presentation, lecturer, discussion, project

11

Learning Media

Lab. equipment and LCD Projector

12

Appraisal

Assignment (20%); Mid Exam (40%); Final Exam (40%)

13

Lecturer

Dr. apt. Rimadani Pratiwi, M.Si., and Dr. apt. Ida Musfiroh, M.Si.

14

References

1. The United States Pharmacopoeia. 2020. United States Pharmacopoeia 2020 USP – 43 NF – 38
   
2. World Health Organization, Guidelines on validation, Appendix 4 Analytical method validation, 2016
   
3. Edla, S dan B.S. Sundhar, 2014. New Analytical Method Development And Validation For The Simultaneous Estimation Of Metformin And Glibenclamide In Bulk And Tablet Dosage Form Using RP-HPLC. Rasayan, J.Chem. Vol 7 (1) : 55-63.
   
4. Birajdar, A.S. 2020. New Method Development by HPLC and Validation as per ICH Guidelines. Acta Scientific Pharmaceutical Science. Vol 4 4) 55-60
   
5. J.C Miller & J.N Miller, Statistika untuk Kimia Analitik, edisi kedua, penerbit ITB.
6. W.F. Pickering, Modern Analytical Chemistry.
7. Chung Chow Chan et al (editor), Analytical Method Validation and Instrument Performance Verification.
8. Susan R. Mikkelsen, et al, Bioanalytical Chemistry.
9. FDA, bioanalytical method validation
10. EMEA, guidance on bioanalytical method validation
11. FDA, Analytical Method Validation, Guidance for industry