Steps in analytical method development

Posted by riya on February 6th, 2020

The development of the pharmaceuticals has brought a revolution in the health of the human and this pharmacological make use of some of the analytical methods to analyze the drug that has been developed. The analytical method development is one of the processes their main purpose is to prove that any analytical method that can be used in the pharmaceutical industry but it should be suitable to be used in the measurement of API. 

Procedure for analytical method development

Here are the procedures that are involved in the analytical development method involves some of the steps, they are mentioned below; 

Purpose

In the pharmacological industry, the analytical method development is very important and they provide valuable information about the pharma solutions like their potency of the drug, bioavailability of the drug, drug stability and also about their effects. The purpose of conducting the analytical method development will be mentioned in the first step.

Record

The steps that are involving during the analytical method development are recorded in the laboratory book to maintain the record.

Characterization of analyte

This step usually includes both the chemical properties and the physical properties of the analyte that is collected. After the collection of the analyte, it should be stored based on their requirements. Later the methods for the analysis are recorded along with the examples, being the chromatography technique they employ the different methods such as the high-performance liquid chromatography.

Requirements definition and review of literature

The requirements for the method development are done and they are recorded. The requirements like the reagents, materials, and instruments are obtained requires the analysis of the sample. The literature review usually contains all the information that is related to the analyte and their references available journals, books, and other publications.

Choosing of analytical methods

From the obtained literature during the review, the specific methodology will be handled and they will be modified based on the analyte present to get the accurate results and also the methods get vary based on the analyte. Suppose if there are no previous methods available for the analyte in the literature then it has been reviewed regarding the character of the analyte, the procedure moves uninterruptedly. The analytical methods are also used in pharma solutions manufacturing. 

Setting the instruments

Appropriate instruments for the method development are set up in the laboratories based on their standard operating procedures. The standard operating procedures are abbreviated as the SOP and they have the set of instructions are steps to perform the specific procedure in the laboratory set up.

Optimization of method

In optimization of the analytical method the parameters usually get changed individually depending on the candidate interests. The optimization of the analytical method can be done about a systematic procedure plan.

Documentation

The analytical figures documentation usually includes the quantification limits, analysis time frame, operational costs, detection limits and sample preparation.

These are all the few steps that are involved in analytical method development and they are very helpful in knowing about the characteristics of the drug