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 dosa...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.展开更多
文摘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.
