Optimization of a Method for the Simultaneous Determination of Phloroglucinol and Trimethylphloroglucinol by High Performance Liquid Chromatography in Routine Use in a Pharmaceutical Industry in Abidjan
In order to provide the population with safe,
effective and good quality medicines, the pharmaceutical industries, before
releasing batches of their products into the pharmaceutical circuit, put in
place internal dosage methods to control the quality of these products. The
present study consisted in optimizing a method for the simultaneous
determination of Phloroglucinol (PHG) and Trimethylphloroglucinol (TPH) by high
performance liquid chromatography (HPLC) routinely used in a pharmaceutical
industry located in a township in Abidjan (Ivory Coast). The basic
chromatographic conditions were those routinely used for the determination of
these two molecules: mobile phase: acetonitrile/water (60/40), stationary phase
(C18 BDS Hypersil 250 mm * 4.6 mm - 5 μm), detection wavelength (265 nm), flow
rate, injection volume and run time configured at the equipment level were
respectively 1 mL/min, 10 μL and 8 min. The method of preparation of the
analytes (PHG and TPHG) was also applied by the pharmaceutical industry. The
application of these different parameters at the equipment level made it
possible to determine a chromatogram which highlights three chromatographic
peaks with respective retention times (RT) of 0.773 min (unidentified compound), 2.275 min (PHG) and 7.269 min for
an analysis time of 8 min with a better resolution of the peaks and baseline.
The progressive optimization of different parameters such as the stationary
phase (C18 YMC 150 mm * 4.6 mm - 3 μm), the proportion of the mobile phase: acetonitrile/water
(80/20), the flow rate impelled by the pump (0.8 mL/min) and the modification
of the analyte preparation mode (same amount of PHG and TPHG in a 50 mL
volumetric flask) resulted in a final chromatogram that highlighted two
chromatographic peaks at the respective RT of 2.391 min (PHG) and 3.735 min (TPHG) at a run time of 6 min. The
chromatographic conditions that led to the final chromatogram can be used
routinely by the pharmaceutical industry for the determination of several PHG
and TPHG drug matrices after prior validation of the determination method.
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