Split calibration curve: an approach to avoid repeat analysis of the samples exceeding ULOQ

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Bioanalysis

Background:

• Traditional bioanalysis uses narrow-range calibration curves, which are time-consuming and have limitations.
• Current methods often require sample dilution and repeat analysis for accurate drug concentration determination.

Purpose of the Study:

• To describe a novel split calibration curve approach for bioanalysis.
• To demonstrate the avoidance of sample dilution and repeat analysis without compromising data quality.

Main Methods:

• Implementation of a split calibration curve strategy.
• Validation of the method for determining drug concentrations in plasma samples.

Main Results:

• The split calibration curve approach accurately determined drug concentrations over wide dynamic ranges (e.g., 0.6-15,000 ng/ml for dapsone).
• Successfully validated for analyzing dapsone, cyclophosphamide, and glipizide in a single run.

Conclusions:

• The split calibration curve method eliminates the need for repeat sample analysis.
• This technique is particularly beneficial for toxicokinetic studies with broad dose ranges and studies with limited sample volumes.