Steps involved in the analytical method development

The analytical method in chemistry is used to find out how the chemical compounds in natural material or synthetic materials are identified, separated and find out their quantity. The analytical method is mainly used to prove any analytical method in the pharmaceutical industry which is used to measure API. Some of the steps are involved in analytical method development. They are

  • Purpose of analytical method development
  • Highlighting of steps
  • Characterization of the Analyte
  • Requirements
  • Review of literature and previous methods
  • Choosing an analytical method
  • Setting up of instruments
  • Optimization of the method
  • Analytical figures of the merit documentation
  • Development method evaluation
  • Analysis of samples

Purpose of analytical method development

The main purpose of the analytical method development in the pharmaceutical industry is providing important information on the potency of the drug, drugs stability, drugs bioavailability, and its effects.

Highlighting of steps

The second step of the analytical method development has recorded the information and data in the laboratory book. This helps to review the information at any time.

Characterization of the Analyte

In the third step, the biological, chemical and physical properties of the analyte are collected. After collecting the information, the analyte is obtained and stored based on its specific requirements. The methods used to analyze the analyte are recorded with the examples using different methods like high-performance liquid chromatography.


Requirements for the analytical method development are done and recorded. All the reagents, materials and instruments which are required for the process are procured.

Review of literature and previous methods

The literature information related to the analyte is necessary to find out their biological and chemical properties. So the records of the journals and books are useful to find out the analyte properties.

Choosing an analytical method

You can modify the specific methodology to get an accurate output using the reviews and information gained from the literature. The methods may need to vary based on the requirements of the analyte. If you can’t find any previous methods in the literature, you can easily proceed with the normal procedure without any disturbance.

Setting up of instruments

The required instruments for the analytical method development are set up based on the standard operating procedures. SOPs means standard operating procedure which is a set of instructions or guidelines to perform the specific procedure in a laboratory set up.

Optimization of the method

The parameters are changed individually based on the arising interest during the optimization of the analytical methods. The optimization of the analytical method is performed in reference to a procedural and systematic plan while making the critically follow the document steps.

Analytical figures of the merit documentation

The documentation of the analytical methods is noted and maintained to review the results. This documentation of the analytical figures includes detecting limits, quantification limits, operational cost, analysis time frame, and sample preparation.

Development method evaluation

The final product of the analysis must give the desired result as expected in the identification of the analyte.

Analysis of samples

In this step, the estimation of the analyte with the example is performed. The result is noted for further reviews.

Final thoughts:

The analytical method development and validation is the continuous process throughout the drug development process.