Analytical Method vs Analytical Method Development explained with clear definitions, key differences, approaches, techniques, applications, and FAQs for pharmaceutical and analytical professionals.
Introduction: Analytical Method vs Analytical Method Development
Analytical Method Development is an innovative and complex scientific process used to design and optimise procedures for identifying, separating, or quantifying chemical substances. In contrast, an Analytical Method is the finalised, established, and documented set of instructions derived from method development, ready for routine use after validation or verification.
The approach adopted during analytical method development determines the reliability and robustness of the analytical method. Whether it is reaction monitoring, impurity profiling, content testing, residual solvent analysis, assay, or characterisation, all quality-related evaluations rely on analytical methods. Hence, analytical methods play a critical role in ensuring the quality, efficacy, and safety of drug substances and drug products.
In this article, I share skill-based, practical knowledge on analytical method development that you can apply directly in real laboratory scenarios. This article will help you clearly understand and answer the following questions:
Related topic: Analytical Method Development and Validation in Pharmaceuticals
An analytical method is a pre-established, approved procedure used to measure the concentration of an active pharmaceutical ingredient (API), impurities, or other components in a drug substance, intermediates, or finished drug product.
Analytical methods are routinely used in:
Analytical method development is the systematic process of establishing analytical parameters and conditions that consistently produce reliable, accurate, and reproducible results for a specific analytical purpose.
Related:
Qualitative analysis focuses on identifying the presence or identity of substances in a sample.
Techniques Used:
Outcome:
Presence or absence of a substance (Yes/No)
Quantitative analysis determines the exact amount or concentration of a substance in a sample.
Techniques Used:
Outcome:
Numerical value (e.g., %, mg/mL, “Each 5 mL contains 100 mg of Paracetamol”)
Key Difference:
Techniques used:
Techniques used:
Techniques used:
Techniques used:
A 7-step systematic approach is recommended:
Determine method type (assay, impurity, identification, content test) and instrument.
Prepare a detailed literature report to support method design.
Plan experiments and define initial conditions.
Optimise parameters such as mobile phase ratio, flow rate, column chemistry, and temperature.
Evaluate precision, linearity, recovery, and analyst-to-analyst reproducibility.
Prepare:
These documents are critical during regulatory audits.
Transfer the method to QC and perform analytical method transfer.
| Aspect | Analytical Method | Analytical Method Development |
|---|---|---|
| Definition | Approved, finalized procedure | Process of establishing method conditions |
| Nature | Fixed and validated | Experimental and innovative |
| Purpose | Routine analysis | To develop a reliable method |
| Documentation | Method/STP | Development report |
| Regulatory Role | Used for compliance | Reviewed during audits |
Analytical method development is one of the most critical and challenging responsibilities of the analytical research department. It requires strong scientific knowledge, innovation, and practical laboratory skills. A well-developed analytical method ensures data integrity, regulatory acceptance, and product quality.
I hope this article has helped elevate your understanding and confidence in analytical method development. Feel free to share your learnings or questions in the comment section.
Related: Pharmaceutical Analysis in QC and ADL | Complete Guide ...
Analytical method development is the process of establishing a set of analytical parameters/conditions that, when executed, give reliable results.
To control the quality of medicine analytical method is required. The analytical development department develops the method in pharma.
There are two types of methods: qualitative and quantitative methods
R&D analytical development develops the method to control the quality of medicine at different stages during the development stage. It also performs other activities like method validation, analytical technology transfer, literature search, etc.
Analytical method development is the 7 steps process which includes Define the aim of the method, Literature search, Design the Analytical Method Development, optimising the Analytical method, verifying the Analytical method, Analytical method development report and STP preparation and Analytical method Transfer
AMD is Analytical method development
HPLC method developments include several steps like selection of column, selection of mobile phase, selection of diluent, selection of wavelength, method optimisation etc.
The efficacy of the medicine depends upon its quality and the quality of a medicine is judge by the analytical method. That is why method development is important.
The analytical method development is required to develop the method to check quality of the medicine.
In the spiking method development known impurity is spiked with a pharmaceutical containing an unknown impurity to identify the unknown impurity.
References
Abbreviation
Quick Links