9 Most important steps for Analytical Method development (AMD)

Analytical method development is a process whose main purpose is to prove if any analytical method in the pharmaceutical industry is suitable for use in the measurement of drug substances or drug products. It plays a vital role in the development and manufacture of pharmaceuticals drug substances or drug products.

Let’s see the 9 most important steps for AMD in the pharmaceutical Industry:

1. Characterization of Analyte: We have to know about the Chemical, biological & physical properties of the analyte such as pKa values, molecular size, and weight, electrical charge, sample solubility, sample volatility, stability and toxicity, hydrophobicity/polarity, chemical/biological reactivity, UV spectra, etc.
2. Literature search & Method requirements: All literature information related to the specific analyte from journals, books, and any other publications. During the literature review, a specific methodology is improved to provide for accurate output and the reason that methods change with the requirements of the analyte.
3. Select the Analysis technique: According to the literature survey, we select the method for HPLC, UV, GC, and LC-MS, and so on.
4. Instrumental setup and Initial studies: Applicable instruments for the analytical method development are set up in the laboratory by each of the instrument's standard operating procedures. They are usually common and standardized for the well-being of use in any laboratory setup.
5. Optimization of Parameters: In carrying out the optimization of the analytical method, parameters are changed individually depending on the arising interests. Optimization of an analytical method is done with a one-time change of one parameter about a systematic and procedural plan.
6. Documentation of Analytical figure: The resultant product of analysis should give a desirable result as expected in the identification of the analyte while making sure to critically follow all the documented steps.
7. Estimation of the method development with the Analyte: These analytical figures of merit include quantification limits, detection limits analysis time frame, operational costs, and sample preparation.
8. Determination of Percent recovery of the Analyte
9. Demonstration of Quantitative sample analysis: Estimation of an analyte with an example being a drug in a matrix sample containing the analyte is done.