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DEVELOPMENT AND VALIDATION OF METHODS OF QUANTITATIVE DETERMINATION OF THE NEW ANTIDIABETIC DRUG IN THE BLOOD PLASMA OF RATS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY WITH MASS SPECTROMETRIC DETECTION

We developed a method of quantification of the new antidiabetic drug 3-(1h-benzimidazole-2-yl)-1,2,2-trimethyl-cyclopentane-carbonic acid (c7070) in the blood plasma of rats by high-performance liquid chromatography with mass-spectrometric detection. The analytical range of the method was 0.02-3876.0 μg in 1 ml of blood plasma. The research was partially supported by the grant of the President of the Russian Federation № MD-4711.2015.7 and МК-6135.2016.4.

Иллюстрации

Figure 1.Representative chromatograms in determining the selectivity.

Table 1.

Determination of the normalized matrix factor in rat plasma.

Figure 2. The linear dependence of peak area С7070 on its concentration normalized to the internal standard.

            Table 2. The accuracy (between the series) of the determination of С7070 in rat plasma.   

Table 3. The accuracy and precision (within the series) of the determination of С7070 in rat plasma.

Table 4. Solution stability upon freezing/defrosting.

Table 5.

Solution stability upon storage in the autosampler.

Figure 3.Chromatography and mass spectra of both С7070 and internal standard (fabomotizol) in rat plasma.
         Thus, the developed method of quantification of C7070 in rat plasma by high-performance liquid chromatography with mass spectrometry is easy to implement, meets the requirements of the validation characteristics, and ensures reliable and accurate determination of C7070 in rat plasma in the concentration range of 0.02 μg/ml to 3876.00 μg/ml.
DOI: 10.18413/2313-8971-2016-2-1-52-57
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