Bioanalytical Method Validation

Aim: Validation of analytical method for quantification of drug concentrations in a biological matrix.


Background information: For studies submitted for regulatory approval or considered for regulatory decisions, validation of bioanalytical methods is mandatory. The objective of the validation of a bioanalytical method is to demonstrate that it is suitable for its intended purpose, ie to measure concentrations of drug and its metabolites in biological samples. The use of a robust and reliable bioanalytical method is critical for a successful drug development project.


Our standard procedure is compliant with GLP/GCP regulations and follow international regulatory standards (ICH) for validation and sample analysis.

Compound requirement: 25 mg


Turnaround time: 6 Weeks / one single analyte in plasma


Experimental design:

Aliquots of drug-free plasma are spiked with the analyte of interest using solutions of reference standard and internal standard to preparate calibration standards and quality control samples. Sample pre-treatment involved a solid-phase or liquid-liquid extraction for clean-up. The compound is identified and quantified using reverse-phase HPLC with MS/MS detection.


Parameters to evaluate:

Matrix Effect
Calibration Curve and Range
Accuracy and Precision
Dilution integrity
Freeze-thaw of the analyte in matrix
Bench top stability in matrix
Long-term stability in matrix
Stability of the analyte in processed samples
Stability of the analyte and IS in stock and working solutions
Reinjection reproducibility

Equipments & facilities:

Mass spectrometry (MS) with both HPLC and ultra-performance liquid chromatography (UPLC), among others. We have spectrometry detectors such as Sciex Triple Quad 6500+ System, API 4000, Waters TQ and Waters TQ Micro.
Extraction and clean-up methods of the biological matrix are mainly based on automated solid phase extraction using Epmotion liquid handling, which helps to obtain reproducible and sensitive methods.
Use of Electronic Notebook avoiding manual data handling.
High capacity to store samples at deep freeze temperatures with a 24/7 temperature monitoring.