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Steps For Analytical Method Development - Pharmaceutical Guidelines

Analytical method development in detail. These are the pharmaceutical guidelines for developing a method of estimation and validating it.

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Anju Narra
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190 views1 page

Steps For Analytical Method Development - Pharmaceutical Guidelines

Analytical method development in detail. These are the pharmaceutical guidelines for developing a method of estimation and validating it.

Uploaded by

Anju Narra
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Steps for Analytical Method Development


An analytical method is developed using many steps. These are the steps which are followed during the development of an analytical method.
Analytical methods in chemistry context entail how chemical components in natural materials or synthetic materials are identified,
separated and then quantified. Analytical method development is a process whose main purpose is to prove if any analytical
method in the pharmaceutical industry is suitable to be used in the measurement of API.

The procedure for analytical method development follows a set of steps as below:
1. Purpose of Analytical Method Development
In the pharmaceutical industry, analytical method development gives important information on the potency of a drug, the drugs'
bioavailability, the drugs' stability and also its effects. In the very first step, the purpose of conducting any Analytical Method
Development is established.

2.Highlighting of Steps
In the second step of Analytical Method Development, the steps involved in the development are recorded in a laboratory book.

3. Characterization of the Analyte


In this step, both the biological and chemical properties in addition to the physical properties of the analyte are collected. After
that, the analyte is obtained and stored according to its specific requirements. The methods for analysis are then recorded with an
example being the chromatography technique which employs different methods such as the High Performance Liquid
Chromatography.

4. Definition of Requirements
Requirements for the method development of the analysis are done and recorded. All the materials, reagents and instruments are
procured those are required for the analysis of the sample.

5. Review of Literature and Previous Methods


All literature information related to the specific analyte e.g. a specific drug is assessed for any biological, chemical and chemical
properties regarding the analyte. Reference is then made from journals, books and any other publications.

6. Choosing an Analytical Method


From the information obtained from the literature during the literature review, a specific methodology is modified to cater for
accurate output and also because methods change with the requirements of the analyte. If there are no previous methods in the
literature being reviewed regarding the analyte, the procedure goes on uninterrupted.

7. Setting up of Instruments
Appropriate instruments for the analytical method development are set up in the laboratory by each of the instruments standard
operating procedures. Standard Operating Procedures usually abbreviated as SOP's are a set of instructions or steps to aid in
performing a specific procedure in a laboratory set up. They are usually universal and standardized for ease of use in any
laboratory set up.

8. Optimization of the Method


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 in reference to a systematic and procedural plan while making sure to critically follow
all the documented steps.

9. Analytical Figures of Merit Documentation


Documentation of the analytical figures of merit decided upon is done. These analytical figures of merit include quantification
limits, detection limits, analysis time frame, operational costs and sample preparation.

10. Development Method Evaluation


The resultant product of analysis should give a desirable result as expected in the identification of the analyte.

11. Sample Estimation, Quantitative Demonstration and Analysis of Samples


Estimation of an analyte with an example being a drug in a matrix sample containing the analyte is done here.

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