M. Kratzel. Two Examples of interactive elearning

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1 M. Kratzel Two Examples of interactive elearning I. Amino acid analysis

2 I. Amino acid analysis 1. Hydrolysis 6 M HCl, 110 C h = amide bond(s)

3 2. Derivatization = Phenylisothiocyanate PTC amino acids 3. Separation HPLC

quantitation Perkin Elmer Applied Biosystems Model 420A PTC

4 4. Sequence confirmation HPLC chromatogram Protein identification using databases (unique amino acid composition required) Exact quantitation Perkin Elmer Applied Biosystems Model 420A PTC Derivatizer with an on-line Perkin Elmer Applied Biosystems Model 130A PTC Amino Acid Analyzer

5 Two didactic aims Hydrolysis 2. Derivatization 3. Separation 4. I II The analytical procedure Evaluation,, Sequence confirmation hplclib Peak library

6 hplclib Peak library hplcnew hplclib impurity profiling separation of enantiomers (on chiral phases) determination of ee Peak library hplcnew

7 Flowchart - Amino acid analysis hplcaaa HPLC chromatogram hplcint Result Which octapeptide from list? Web pages - Amino acid analysis

8 Flowchart - Amino acid analysis hplcaaa HPLC chromatogram hplcint Result Which octapeptide from list? Web pages - Sample download

9 Flowchart - Amino acid analysis hplcaaa HPLC chromatogram hplcint Result Which octapeptide from list?

10 Flowchart - Amino acid analysis hplcaaa HPLC chromatogram hplcint Result Which octapeptide from list? Some (but no more) comments on evaluation: 1. The reference samples contain amino acids in equimolar amounts. Different peak areas refer to different UV absorption of PTC derivatives. 2. The result comprises the relative (molar) amounts of present amino acids. 3. And which octapeptide relates to your result?

12 II. Assay Validation ICH parameters versus type of validation

13 Validation plan Assay of Nitrendipine by HPLC I. System Suitability II. Specifity III. Precision IV. Linearity V. LOD + LOQ (VI. Range) included in IV. Linearity VII. Accuracy VIII. Precision - Repeatability IX: Precision - Intermediate precision Flowchart - Assay validation Working file generator Working File hplcsim Evaluation tool Results + Working File Validation report Web form

14 Flowchart - Assay validation Working file generator Working File hplcsim Evaluation tool Results + Working File Validation report Web form Web pages - Assay validation

15 Flowchart - Assay validation Working file generator Working File hplcsim Evaluation tool Results + Working File Validation report Web form Flowchart - Assay validation Working file generator Working File hplcsim Evaluation tool Results + Working File Validation report Web form

16 Web form - Validation report Flowchart - Assay validation Working file generator Working File hplcsim Evaluation tool Results + Working File Validation report Web form

vii LIST OF TABLES TABLE NO DESCRIPTION PAGE 1.1 System Suitability Parameters and Recommendations Acidic and Alkaline Hydrolysis 15

vii LIST OF TABLES TABLE NO DESCRIPTION PAGE CHAPTER- 1 1.1 System Suitability Parameters and Recommendations 07 1.2 Acidic and Alkaline Hydrolysis 15 1.3 Oxidative Degradation Study 16 1.4 Hydrolysis