method development

What are the Key Steps in Method Development?

The key steps in method development include:
1. Literature Review: Before starting, it’s essential to review existing methods and understand the challenges and limitations.
2. Selection of Analytical Technique: Choose the appropriate technique such as HPLC, LC-MS/MS, or ELISA based on the analyte and matrix.
3. Optimization: Adjust the parameters (e.g., pH, temperature, mobile phase composition) to achieve the best separation and detection.
4. Validation: Validate the method by testing its accuracy, precision, sensitivity, specificity, and robustness.
5. Documentation and Standard Operating Procedures (SOPs): Document the entire process and create SOPs to ensure consistency.

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