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Development and validation of bioanalytical methods

Development and validation of bioanalytical methods

The development and validation of bioanalytical techniques for the determination of drugs in biological matrices by HPLC-MS/MS (plasma, blood, urine, human and animal saliva) is carried out in accordance with current regulatory requirements.

Liquid chromatography with mass spectrometric detection (HPLC-MS/MS) is one of the most popular methods in modern analytical chemistry. The advantages of this method are its high accuracy and sensitivity.

It is used to analyze a wide variety of biological fluids: blood, urine, and saliva. The content of drugs, biological substances, disease markers, doping and toxins can be studied in the samples. We cooperate with a large number of pharmaceutical companies which use our data for studying properties, drug development and registration.

Individual approach is used to develop methods for each analyte

The Laboratory has various types of sample preparations: precipitation (precipitation of blood plasma proteins with acetonitrile and other precipitators), liquid-liquid extraction followed by concentration.

For work with unstable analytes in the Exacte Labs bioanalytical laboratory, the possibility of work under yellow light, under cooling conditions - the use of an ice bath, as well as the selection of stabilizers.

For development and validation of methods for particularly difficult projects (very low sensitivity, endogenous compounds, unstable analytes), we have assembled a team of experts with more than 5 years of experience in development and validation of methods for determination of drugs.


Bioanalytical research requires expensive equipment and highly qualified staff. The group has 18 HPLC-MS/MS systems, 8 of which are in the Bioanalytical Department of Exacte Labs. All mass spectrometers in the laboratory are manufactured by Sciex, and liquid chromatographs from leading world manufacturers Agilent, Shimadzu, Waters. Each system has redundant equipment, sufficient spare parts stock and in-house service to ensure uninterrupted instrument operation.

Why is it worth ordering method development and validation from Exacte Labs?

Exacta Labs quality management system is certified to ISO 9001:2015, GLP principles of Good Laboratory Practice, and ISO 17025 (in the Russian accreditation system GOST ISO/IEC 17025).

More than 300 developed and validated methods (whole blood, serum, urine).

We can provide additional service - ordering of standards.

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