Question

A Quality Assurance manager conducts tests to determine the ability of a developed analytical method to accurately detect and respond to changes in various parameters. The tested parameter is called as __________.

• A. accuracy
• B. precision
• C. sensitivity
• D. specificity

Hint:

Think of analytical attributes this way: - Accuracy = Nearness to the true bullseye. - Precision = Consistency of grouped shots. - Sensitivity = How small of a change can create a visible movement in the instrument's signal.

Answer 1

The Correct Option is C

Understanding the Concept: Method validation in pharmaceutical analysis involves proving that an analytical procedure is suitable for its intended purpose. Various distinct performance parameters are evaluated according to guidelines such as the ICH Q2(R1).

Step 1: Define the technical terms
• Accuracy: The closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.
• Precision: The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions.
• Sensitivity: The capacity of an analytical method to record small variations or changes in concentration or other operational parameters. It measures the rate of change of response with respect to the analyte concentration (represented as the slope of the calibration curve).
• Specificity: The ability to assess unequivocally the analyte in the presence of components which may be expected to be present (such as impurities, degradants, or matrix blanks).

Step 2: Align the question text with the parameters The question specifically highlights "the ability... to accurately detect and respond to changes in various parameters." This direct relational responsiveness to changing conditions or small increments defines the method's sensitivity.