Table of Contents
- Method Validation
- HPLC Method Development
- GC Method Development Course
- Chiral Method Development
- Impurities Control Strategies
- Free Pharmaceutical Courses
- Courses As Per Requirement
PharmaGuru course syllabus, including method validation, HPLC and GC method development, chiral method development, impurity control strategies, and more. Learn the skills and techniques required for a successful career in the pharmaceutical industry with our free and comprehensive courses
PharmaGuru Course Syllabus
Method Validation Course
- Need for AMV (Analytical method validation)
- Method classification and its corresponding validation requirement
- A brief discussion of different guidelines
- Validation parameters
- How to design a strategy for effective analytical method Validation?
- What is the pre-validation work?
- Necessary components required to perform Analytical method validation
- How to decide the validation parameters?
- How to design and write a method validation protocol?
- How to perform specificity?
- How to perform DL and QL?
- How to perform precision (System repeatability, method repeatability, intermediate precision and method reproducibility)?
- How to perform linearity and range?
- How to calculate RRF?
- How to perform accuracy and recovery?
- How to perform stability of solution?
- How to perform robustness?
- FAQs and doubt clearance
- Activities after validation
- How to prepare report?
- Report approval process
- How to perform validation of the pharmacopoeias method?
- A Bird’s eye view on cross validation
- A Bird’s eye view on re-validation
- Case studies
- FAQs and Interview Questions
- Bonus
- How to deal with validation parameter test failure
- How to avoid common mistakes during method validation
- How to avoid regulatory queries and deficiency letters related to validation
HPLC Method Development Course
- Analytical method development?
- Why are chromatographic techniques needed?
- A Birds Eye View on Commonly used chromatographic techniques
- HPLC and its components
- How to read a chromatogram?
- RT, RRT, area response and peak height
- Types of chromatography
- HPLC operating parameters
- Basic separation mechanism
- Detectors
- Chromatographic terms and System suitability test parameters (K, N, R, T, As, HETP, RSD, DL, QL. As)
- Mobile Phase Chemistry
- Type of Elution mode
- Column chemistry
- A bird’s Eye view on different Analytical tests
- Advantages and disadvantages of HPLC
- Role NPC, RPC and IP-RPC in HPLC method development
- pH and its role in HPLC method development
- pKa and its role in HPLC method development
- Role of polarity in HPLC method development
- How to equilibrate the column faster?
- Elution mode selection: Isocratic vs Gradient: advantages and disadvantages
- Modes of calculation
- How to prepare solutions of different concentrations (mcg, ppm etc)
- Different components of the HPLC method
- Precautions required during HPLC analysis
- Compounds classification based on polarity
- HPLC Separation principle
- A Bird’s Eye view on HPLC separation mechanism
- How to predict elution order?
- RFT approach in HPLC method development
- Method development steps
- Sample preparation procedures
- Chromatographic mode selection
- Column selection procedure
- Mobile phase selection procedure
- Selection of buffer (type and concentration)
- Selection of modifier
- Solvent selection and optimization
- Detector Selection and role of PDA detector in HPLC method development
- Calculation mode selection
- How to optimize retention time?
- Method Optimization in gradient and isocratic mode(Temperature, sample concentration, injection volume, flow rate, wavelength and separation)
- Characteristics of a newly developed HPLC method
- HPLC Method verification
- Common HPLC troubleshooting
- How to reduce noise?
- How to deal with over pressure in the column?
- How to deal with column equilibration issue?
- How to deal with SST failure issue?
- How to deal with mobile phase precipitation?
- How to increase the HPLC column life?
- Brief discussion on column care
- Separation of a mixture of nonpolar, polar acidic, polar basic, strongly acidic and strongly basic compounds
- How to develop a cost-effective method
- How to develop HPLC-MS compatible method?
- How to peak integration?
- How to check peak purity?
- Case Studies (7 to 11)
- Exercise
- FAQs and Interview questions
GC Method Development Course
- Principle of Gas Chromatography
- Components of Gas chromatography and their function
- Types of Gas Chromatography
- Detectors used in GC
- GC column chemistry
- GC column selection
- GC method development steps
- How to choose split and splitless liners?
- How to develop a cost-effective GC system?
- How to decide GC method system suitability?
- Modes of calculation
- Factors affecting GC analysis
- How to prepare a sample and standard solution?
- Test performed by GC
- How to decide system suitability?
- Factors affecting GC separation
- Applications of Gas Chromatography
- Case studies (at least 5)
- Allowable adjustment in the GC method
- How to prepare GC method
- How to verify GCHS method
- Principle of GC-HS
- Components of GCHS
- GCHS analysis procedure
- GC-HS method development steps
- How to decide GCHS diluent?
- Case studies (at least 5)
- How to prepare the GC-HS method
- How to verify GCHS method?
- FAQs and Interview Questions on GC and GCHS
Chiral Method Development Course
Chiral and Achiral molecules, Enantiomers, Diastereomers, Racemate and Meso-form, RS Nomenclature, Importance of Chiral separation, Thalidomide tragedy, analytical techniques for Chiral separation, Chiral Stationary Phases (CSPs) Chemistry, HPLC chiral column selection, GC chiral column selection, Chiral separation method development steps, QBD approach in Chiral method development, Chiral method development of molecule containing 1 or 2 chiral centers, How to optimize Chiral method, Case studies (at least 5 to 7), Advancements in Chiral GC, Can Achiral impurities be separated along with Chiral isomers?, and Common troubleshooting during chiral method development….
Impurities Control Strategies Course
What is the Impurities Control Strategies? Impurities classification. Sources and control of Impurities in pharmaceuticals such as Achiral impurities, Chiral impurities, Isomeric impurities, Elemental Impurities, and Degradation Impurities. How, Where and at What level should Impurities be controlled? Detail discussion of the formation of Impurities. Genotoxic impurities and their control strategies. Genotoxic chemicals and their chemical properties. Factors affecting Genotoxicity. Purge factor calculation. Impurities classification (Class-1, Class-2, Class-3, Class-4 and Class-5). TTC (threshold of toxicological concern) concept. Structure Alerts (SAs) concept/In silico system for Identification of Genotoxins. Challenges with Insilco predictions. Genotoxicity and Mutagenicity. Nitrosamines in Pharmaceutical and their control strategy. Approaches to Identify and Control the Unknown Impurities. FAQs on Impurities Control Strategies. ​
Free Pharmaceutical Courses
Choose the course as per your choice from the following table:
| HPLC Technique | GC Technique | FTIR Technique |
| Titration Technique | UV-Vis Spectrophotometer | KF (Karl Fisher) Technique |
| OOS and OOT | GLP | GDP |
| SOP | Data integrity | STP Preparation |
| Mobile Phase Preparation | Analytical Solution preparation | HPLC Column washing |
| Pharmaceutical Analytical Techniques | System suitability test | Different pharmaceutical tests |
| GCHS Techniques | GCMS techniques | LCMS Techniques |
| UV Spectro photometer Calibration | HPLC Calibration | UPLC Calibration |
| GC Calibration | KF calibration | Analytical Literature Report |
| Carriers in Pharmaceutical Industries | CAPA | How to Prepare QC Monograph |
| Internal audit | HPLC Troubleshooting | HPLC Troubleshooting |
| How to perform impurity profile test? | How to perform assay test? | How to perform content test? |
Courses As Per Requirement
In this categories, courses are provided as per the Customer requirements: Contact Us