E18-13: Develop Robust HPLC Methods for Pharmaceutical Analyses

One-Day Course 
Sunday, Nov. 11; 8:30am – 5:00pm

Dr. Jinjian Zheng, Merck & Co. Inc., Rahway, NJ

In this one-day short course, we will discuss a systematic approach to develop robust HPLC methods for pharmaceutical analyses. Many challenging real life examples will be analyzed to understand what it takes to develop a robust HPLC method for various applications including assay/CU/dissolution, impurity profiling/stability indicating, mutagenic impurities etc. The application of software modeling tools in each stage of the method development will be discussed. In addition, we will discuss the approaches to minimize method uncertainties and reduce errors in quantitative analysis based on measurement system analysis principles.

Scientists who have hands-on experience in HPLC and wish to improve their skills in HPLC method development.

1. Preparation
a. Understand physico-chemical properties of your analytes
b. Understand physico-chemical properties of your analytes
c. Prepare representative sample mixtures
2. Screening for Stationary Phases and Mobile Phases
a. Selection of separation mode, stationary phases and mobile phases
b. Generic screening vs. focused screening
c. Automated DOE experimentation
3. Method Optimization through Modeling
a. Benefits of software modeling
b. Limitation of software modeling
c. Live demonstration of modeling software
4. Method Characterization
a. Evaluation of method robustness through DOE
b. Analysis of method uncertainty using measurement system analysis
     c. Development of sound control strategies

Dr. Jinjian Zheng is currently a principal scientist at Analytical Commercialization Technologies department, Merck & Co. Inc., where he has worked for 15 years. Dr. Zheng has developed and validated numerous HPLC methods to support the development and commercialization of both drug substances and drug products. He has extensive hands-on experience in HPLC method development using modeling software including ACD/Labs, ChromSword, DryLab and Fusion QbD. He is currently leading the efforts at Merck for efficient HPLC method development using quality by design (QbD) approaches.