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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

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Open Journal of Optimization 2023年第2期12卷 11-24页

作者： Jean-Kisito Kouamé Mariette Désirée Yéhé Claude Bérenger Ngalemo Ngantchouko Amani Germain Brou carine nina ablé Aya Mélissa Diane Kouadio Bi Gogoua Désiré Vagny Vincent De Paul Ovi Christophe N’cho Amin Gildas Komenan Gbassi National Public Health Laboratory (NPHL) Food Control Service Abidjan Ivory Coast Department of Analytical Sciences and Public Health Training and Research Unit (UFR) of Pharmaceutical and Biological Sciences Félix Houphou&#235t Boigny University Abidjan Ivory Coast Higher Institute of Health Sciences of the University of the Mountains (UdM) Bangangté Cameroon

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 dete

关键词： PHG TPHG Pharmaceutical Industry Chromatographic Profile Chromatographic Peak

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Influence of Some Physico-Chemical Exposure Factors on the Carbocysteine Content of an Opened Pharmaceutical Product

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American Journal of Analytical Chemistry 2022年第12期13卷 495-505页

作者： Jean-Kisito Kouame Mariette Desiree Yehe carine nina able Vincent De Paul Ovi Hervé Tazoh Broh Claude Bérenger Ngalemo Ngantchouko Gildas Komenan Gbassi National Public Health Laboratory (NPHL) Food Control Service Abidjan Ivory Coast Department of Analytical Sciences and Public Health UFR Pharmaceutical and Biological Sciences Félix Houphou&euml t Boigny University Abidjan Ivory Coast

The aim of this study was to investigate the stability of Carbocysteine (CBC) contained in a reference substance (RS) and in a sample of opened RHINATHIOL® 5% syrup (RNTL 5%) under the effect of some physicochemical parameters (temperature, light, time, pH, bile salts). The developed method was linear, precise and accurate according to USP 38. The co-efficient of determination R2 for linearity was 0.9993. The respective RSD of intra-day and inter-day between days (1st, 2nd and 3rd day) were respectively 0.338% and the interval from 0.05% to 0.387%. The average recovery rate ranged from 98.490% to 100.450%. The detection and quantification limits were 0.0001 mg/mL and 0.001 mg/mL respectively. The method was applied to four samples of opened syrup containing CBC and the CBC content in these samples was found to be in accordance with USP 38. The CBC content in the opened sample of RNTL 5% was obtained by UV-visible spectrophotometry at 217 nm and was 4.887 g/100mL. The study of the influence of physico-chemical factors on the content of CBC in RS and RNTL 5% showed that the evolution of CBC contents in each drug matrix remained dependent on pH and temperature. However, these levels remained stable in the presence of light.

关键词： Influence Physico-Chemistry Content Carbocysteine Stability

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