Important Steps for GC Method Development

GC Method Development 

Method development plays a vital role in the discovery, development, and manufacture of pharmaceuticals. 

Method development is the process of proving that an analytical method is suitable for intending purpose to measure the concentration of an API in a specific compound, which allows simplified procedures to be employed to prove that an analysis procedure is accurate and consistent.

Method development is required due to 

1. Developing new molecules or products when no official methods are available. 

2. An alternate method for existing products is to reduce the cost and time for better precision and ruggedness.  

Steps for GC Method development: 

1. Physicochemical properties of the sample.
2. Selection of chromatographic conditions
3. Developing the approach of analysis
4. Sample preparation
5. Method optimization
6. Method validation