Discussion
According to FDA guidelines for method validation by LC-MS, which of the following is not a relevant parameter :
Answer: C
The parameter that is not part of bioanalytical method validation is retention.
The US FDA's guidance on bioanalytical method validation for chromatographic methods such as LC-MS lists the parameters to be established: selectivity, accuracy, precision, sensitivity (the lower limit of quantification), the calibration curve, recovery, reproducibility, stability of the analyte, and for LC-MS also matrix effect, dilution integrity and carry-over.
Accuracy, precision and carry-over are therefore all validation parameters. Retention time is used to identify the analyte in a chromatogram, but it is a property of the analysis rather than one of the validation characteristics the guidance requires.
Post your comment
Please log in or register to post a comment.
Examination Categories
- SSC Exams
- Banking Exams
- Teaching Exams
- Civil Services Exams
- Railways Exams
- Engineering Recruitment Exams
- Defence Exams
- State Government Exams
- Police Exams
- Insurance Exams
- Nursing Exams
- Other Government Exams
- NRA CET
- PG Entrance Exams
- Campus Placement
- MBA Entrance Exams
- CUET and UG Entrance
- Judiciary Exams
- Regulatory Body Exams
- Software Development