HPLC Method Development – Advanced Training

Description

HPLC Method Development – Advanced Training Program

Master the Science and Art of HPLC Method Development

The PharmaGuru HPLC Method Development Advanced Training Program is designed to equip analytical professionals with the practical knowledge and hands-on strategies required to develop, optimise, troubleshoot, validate, and transfer robust HPLC methods.

This comprehensive program covers Quality by Design (QbD)-based method development principles, column chemistry selection, mobile phase optimisation, pH and buffer selection, gradient design, impurity profiling, troubleshooting techniques, regulatory expectations, and numerous real-world case studies from the pharmaceutical industry.

Module 1: Introduction to HPLC

• Welcome to PharmaGuru
• Why is HPLC Required?
• Historical Background and Principles of HPLC
• Key Components of HPLC and Their Functions
• Peak Formation in HPLC
• Applications of HPLC
• Advantages and Limitations of HPLC
• Interactive Question & Answer Session
• Overview of PharmaGuru Online Courses

Module 2: Fundamentals of Chromatographic Separation

• Separation Mechanisms in HPLC
• Components of an HPLC Chromatogram
• Guard Filters, Guard Columns, and Ghostbuster Columns
• Important Chromatographic Parameters:
  • Theoretical Plates (N)
  • Resolution (Rs)
  • Tailing Factor (T)
  • Capacity Factor (K)
  • Selectivity (α)
• Role of Partition, Adsorption, & Ion-Exchange Mechanisms in Separation Efficiency
• HPLC Detectors and Their Applications
• Interactive Question & Answer Session

Module 3: HPLC Modes and Column Selection

• HPLC Modes: Reverse Phase Chromatography (RPC) and Normal Phase Chromatography (NPC)
• HPLC Column Chemistry and Selection Strategy
• Equivalent HPLC Columns and Their Applications
• Modes of Elution:
  • Isocratic Elution
  • Gradient Elution
• HPLC Column Equilibration Best Practices
• How to Set Up an HPLC System Efficiently
• Peak Integration in HPLC

Module 4: System Suitability and HPLC Calculations

• System Suitability Testing (SST):
  • Components
  • Acceptance Criteria
• Void Volume, Dead Volume, and Dwell Volume in HPLC
• Important HPLC Equations and Their Applications
• Various Calculation Approaches in HPLC Analysis
• Role of Relative Response Factors (RRF) in Impurity Calculations

Module 5: Mobile Phase Chemistry and Optimisation

• Mobile Phase Chemistry and Selection Strategy
• Mobile Phase Preparation: Best Practices and Common Mistakes
• Mobile Phase Modifiers and pH Selection
• Role of pKa in Reverse Phase HPLC Method Development
• HPLC Water Quality Requirements
• Common HPLC Solvents and Their Applications
• Understanding Ghost Peaks and the Role of Ghostbuster Columns

Module 6: HPLC Method Development Strategies

Assay Methods

• Step-by-Step Assay Method Development

Related Substances and Impurity Profiling

• Method Development for Related Substances
• Impurity Profiling Approaches

Chromatographic Modes

• Normal Phase Chromatography (NPC)
• Reverse Phase Chromatography (RPC)
• Ion-Pair Reverse Phase Chromatography (IPRPC)

Module 7: Case Studies – Simple Molecules

• Real-World Case Studies on Method Development for Simple Molecules
• Strategies for Compounds Containing Fewer Than Five Impurities
• Practical Approaches to Method Optimisation and Validation

Module 8: Case Studies – Complex Molecules

• Method Development for Complex Molecules Containing More Than Five Impurities
• Structured Strategies for Multi-Impurity Separation
• Managing Co-Elution Challenges
• Gradient Design and Optimisation
• Selectivity Tuning Approaches
• Peak Tracking Techniques
• System Suitability Mapping

Module 9: Separation of Isomers and Diastereomers

• Advanced Separation Strategies for:
  • Positional Isomers
  • Stereoisomers
  • Diastereomers
• Using pH to Improve Selectivity
• Role of Organic Modifiers in Challenging Separations
• Leveraging Column Chemistry for Enhanced Resolution
• Real-World Approaches for Resolving Closely Eluting and Overlapping Peaks

Module 10: Method Optimisation and Finalisation

• Complete Workflow:
  • Method Screening
  • Optimisation
  • Robustness Evaluation
  • Method Finalisation
• Finalising:
  • Gradient Programs
  • Buffer Strength
  • Mobile Phase pH
  • Flow Rate
  • Column Temperature
• Ensuring Method Ruggedness for Routine QC Environments

Module 11: Cost Reduction, Troubleshooting and Advanced Concepts

• Key Strategies to Reduce HPLC Method Development Costs
• Right First Time (RFT) Approach
• HPLC Method Adjustment Techniques
• Managing System Suitability Failures
• PDA/DAD Detectors and Peak Purity Assessment
• Comprehensive HPLC Troubleshooting:
  • Common Problems
  • Root Cause Analysis
  • Practical Solutions
• Introduction to:
  • Supercritical Fluid Chromatography (SFC)
  • Ion Exchange Chromatography (IEC)

Module 12: Method Transfer, Regulatory Compliance and Career Preparation

• HPLC Method Adjustment and System Suitability Failure Investigation
• PDA/DAD Detector Applications and Peak Purity Evaluation
• Advanced HPLC Troubleshooting Techniques
• Top HPLC Interview Questions and Expert Answers
• Open Doubt-Clearing Session
• Method Verification Principles
• Method Development Report Writing
• Method Transfer to Quality Control (QC) Laboratories
• Regulatory Expectations for Analytical Methods
• Common Regulatory Deficiency Observations and Responses
• Preparing a Complete Method Development Report with Scientific Justification and Data Summaries

Training Details

Duration

• 12 Sessions
• Total Duration: 18 Hours (1080 Minutes)

Target Audience

• Analytical Development Scientists
• Quality Control (QC) Professionals
• Quality Assurance (QA) Professionals
• Regulatory Affairs (RA) Personnel
• Research & Development (R&D) Scientists

Training Mode

• Online Live Training via Google Meet

Certification

• Certificate of Completion will be awarded to all participants.

Money-Back Guarantee

• 30-Day Money-Back Guarantee

Language

• English

Instructor

Dr. Pramod Kumar Pandey (Ph.D. in Chemistry)

• More than 31 years of experience in global and Indian pharmaceutical industries.
• Extensive expertise in analytical method development, validation, troubleshooting, regulatory compliance, and pharmaceutical quality systems.

Flexible Learning Options

This training program is available in multiple formats to suit individual and organisational needs:

• Classroom (In-Person) Training
• Online Foundation Course
• Online Most Popular Course
• Online Advanced Course
• Customised Corporate Training Programs