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Analytical Method Validation

The document outlines the principles of analytical method validation, including specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, robustness, ruggedness, and system suitability testing. Each principle is defined with its significance and measurement methods. Additionally, it references relevant regulatory guidelines such as WHO TRS 957, ICH Q2(R2), USP <1225>, and CDSCO/IP.

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22 views2 pages

Analytical Method Validation

The document outlines the principles of analytical method validation, including specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, robustness, ruggedness, and system suitability testing. Each principle is defined with its significance and measurement methods. Additionally, it references relevant regulatory guidelines such as WHO TRS 957, ICH Q2(R2), USP <1225>, and CDSCO/IP.

Uploaded by

pankajchoudhary4819
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We take content rights seriously. If you suspect this is your content, claim it here.
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Analytical Method Validation Principles

1. Specificity (Selectivity)
Ability of the method to measure the analyte accurately in the presence of components such
as impurities, degradation products, or matrix (excipients in formulations). Ensures no
interference from other substances.

2. Linearity
Ability of the method to elicit test results that are directly proportional to the concentration
of analyte in the sample. Assessed across a given range (typically using a regression line and
correlation coefficient r ≥ 0.999 is considered ideal).

3. Accuracy
Closeness of test results to the true value or accepted reference value. Measured by
recovery studies (e.g., spiking known amounts of analyte).

4. Precision
Divided into:
- Repeatability (Intra-day precision): Same analyst, same equipment, short interval.
- Intermediate precision: Different analysts, days, or equipment within the same lab.
- Reproducibility: Between different laboratories (used in inter-lab studies).
Measured as %RSD (Relative Standard Deviation).

5. Range
The interval between the upper and lower levels of analyte that have been demonstrated to
be determined with acceptable precision, accuracy, and linearity.

6. Detection Limit (LOD)


The smallest amount of analyte that can be detected but not necessarily quantified.
Common methods: Signal-to-noise ratio (3:1), standard deviation method.

7. Quantitation Limit (LOQ)


Lowest amount of analyte that can be quantitatively determined with acceptable accuracy
and precision. Common methods: Signal-to-noise ratio (10:1), standard deviation method.

8. Robustness
Ability of a method to remain unaffected by small, deliberate variations in method
parameters (like pH, temperature, flow rate). Indicates the method’s reliability under
routine use.

9. Ruggedness
Reproducibility under normal, but variable conditions (analyst, instrument, lab), showing
consistency over a broader range of conditions than robustness.
10. System Suitability Testing
Done before analysis begins to verify that the system (e.g., HPLC, GC) is working properly.
Parameters include resolution, tailing factor, theoretical plates, and %RSD of replicate
injections.

Regulatory Guidlines
WHO TRS 957

ICH Q2(R2)

USP <1225>

CDSCO/IP

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