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Pharmacokinetics of levosulpiride after single and multiple intramuscular administrations in healthy Chinese volunteers

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Acta Pharmaceutica Sinica B 2014年第5期4卷 402-407页

作者： Chuting Gong janvier engelbert agbokponto Wen Yang Ernest Simpemba Xiaohong Zheng Quanying Zhang Li Ding Department of Pharmaceutical Analysis China Pharmaceutical UniversityNanjing 210009China Organization for State Drug Clinical Trial the Second Affiliated Hospital of Soochow UniversitySuzhou 215004China

The main purpose of this study was to evaluate the pharmacokinetics of levosulpiride in humans after single and multiple intramuscular *** males and six females received single dose of either 25 mg or 50 mg levosulpiride,or multiple doses of 25 mg every 12 h for 5 consecutive *** the single 25 mg study,the mean peak plasma concentration(C max)was 441 ng/mL,the mean area under the concentration–time curve from 0 to 36 h(AUC_(0–36))was 1724 ng h/mL,and the mean elimination half-life(t_(1/2))was 7.0 *** the single 50 mg study,the mean C max was 823 ng/mL,the mean AUC_(0–36) was 3748 ng·h/mL,and the mean t_(1/2) was 6.8 *** multiple doses of 25 mg levosulpiride,the average plasma concentration(C av)was 136 ng/mL,the fluctuation index(DF)was 3.60,and the accumulation ratio(R)was *** injections appeared to be well tolerated by the subjects,and can be used for successive administration.

关键词： Levosulpiride Pharmacokinetics Intramuscular administration Safety and tolerability

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Simultaneous Determination by HPLC-UV Vis of Tartrazine and Sunset Yellow in Soft Drinks Sold in Benin

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American Journal of Analytical Chemistry 2022年第8期13卷 277-288页

作者： janvier engelbert agbokponto André Philippe S. Kpaibe Loconon Achille Yemoa Assogba Gabin Assanhou Habib Ganfon Gildas Komenan Gbassi Michèle Aké N’cho Christoph Amin Laboratoire de Chimie Analytique et d’Analyse des Médicaments UFR Pharmacie Faculté des Sciences de la Santé Université d’Abomey-Calavi Cotonou Bénin UFR Pharmacie Faculté des Sciences de la Santé Université d’Abomey-Calavi Cotonou Bénin Département de Chimie Analytique Bromatologie Chimie Générale et Minérale UFR des Sciences Pharmaceutiques et Biologiques Université Félix Houphou&euml t-Boigny Abidjan C&ocirc te d’Ivoire

The use of dyes such as tartrazine (E102) and sunset yellow (E102) in food, beverages and health products for technological and commercial purposes is common. The adverse effects caused by these dyes, such as allergies and hyperactivity disorder have been reported, especially in children. In the present study, a chromatographic method was developed and validated for simultaneous determination of tartrazine and sunset yellow. The chromatographic separation was performed on a Lichrocart® C18 column (125 × 4.6 mm;5 μm) with a security Guard-C18 column (4 × 2.0 mm, 5 μm;Phenomenex, Torrance, CA, USA) maintained at 30°C. The mobile phase consisted of a mixture of acetonitrile/ammonium acetate buffer pH 6.8 in gradient mode with a flow rate of 1 mL/min. The injection volume was 10 μL. The detection wavelength was set at 455 nm. The parameters of specificity, linearity, precision, repeatability, accuracy and sensitivity were examined for validation. The developed method is linear in the range of 1 μg/mL to 100 μg/mL with a R2> 0.998. The intra-day and inter-day precisions (RSD) were less than 0.6% and 3.1% respectively. The detection limit was 0.03 μg/mL and the quantification limit was 0.1 μg/mL. The retention time of tartrazine was 2.86 min, while sunset yellow was detected at 5.67 min. A simple, rapid, accurate and robust HPLC/UV-Visible method was developed and validated for simultaneous identification and quantification of tartrazine and sunset yellow. This developed method was successfully applied for the simultaneous determination of tartrazine and sunset yellow in soft drinks sold in Benin.

关键词： Tartrazine Sunset Yellow HPLC-UV Food Dyes

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苯环喹溴铵鼻喷雾剂和布地奈德鼻喷雾剂联合用药在人体内的药代动力学相互作用

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中国药科大学学报 2013年第5期44卷 447-450页

作者：钟水生罗柱孙鲁宁恩格百特梁茂植丁黎中国药科大学药物分析教研室南京210009 四川大学华西医院临床药理研究室成都610041

考察苯环喹溴铵鼻喷雾剂(BCQB)与布地奈德鼻喷雾剂(BUD)联用时在人体内的药代动力学相互作用。采用随机、两周期、序贯交叉、多次给药试验设计,12名男性健康受试者随机分成两组:Ⅰ组受试者序贯单次鼻腔给药BCQB180μg,连续给药BCQB 6 d... 详细信息

考察苯环喹溴铵鼻喷雾剂(BCQB)与布地奈德鼻喷雾剂(BUD)联用时在人体内的药代动力学相互作用。采用随机、两周期、序贯交叉、多次给药试验设计,12名男性健康受试者随机分成两组:Ⅰ组受试者序贯单次鼻腔给药BCQB180μg,连续给药BCQB 6 d(一天4次,每次180μg),联合给药(BCQB 180μg和BUD 256μg);Ⅱ组受试者序贯单次鼻腔给药BUD 256μg,连续给药BUD 7 d(一天1次,每次256μg),联合给药(BUD 256μg和BCQB 180μg)。一周清洗期后两组交换给药方式继续进行试验。采用LC-MS/MS法分别测定受试者给药后血浆中苯环喹溴铵与布地奈德的血药浓度。计算BCQB和BUD单用及联用两种用药方式下的药代动力学参数c max、AUC、t max,并进行统计分析。结果表明,BCQB与BUD联合用药不存在显著的体内药代动力学相互作用。

关键词：苯环喹溴铵布地奈德药代动力学药物相互作用 LC—MS MS 鼻喷雾剂

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Quality Control of Paracetamol Generic Tablets Marketed in Benin and Search of Its Two Impurities P-Aminophenol and P-Nitrophenol by HPLC-UV/Visible

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American Journal of Analytical Chemistry 2022年第11期13卷 449-460页

作者： Yemoa Loconon Achille agbokponto janvier engelbert Assanhou Assogba Gabin Adetona Pauline Doffon Parfait Ganfon Habib Roland Marini Djang’eing’a Laboratoire de Chimie analytique et Analyse des Médicaments Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé. Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacie Galénique et de Technologie Pharmaceutique Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacognosie et de de Phytothérapie Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Chimie Analytique Pharmaceutique Departement de Pharmacie Université de Liège (ULiège) Liège Belgium

In this work, we evaluated the quality of paracetamol generic tablets while seeking its two main impurities namely 4-para-aminophenol (4-AP) and 4-para-nitrophenol (4-NP) which have nephrotoxic and teratogenic properties. Ninety-four (94) samples were collected at various levels of the medicine supply chain and illegal markets in Benin for quality control tests such as visual inspection, pharmacotechnical tests as mass variation, disintegration test, dissolution test, followed by HPLC UV-Vis identification and assay of paracetamol, 4-AP and 4-NP. The analytes were separated on C18 Lichrocart column (250 mm × 4.0 mm i.d, 5 μm);the mobile phase was MeOH:10 mM ammonium acetate buffer pH 6.8 (35:65) pumped at a flow rate of 1 ml/min. The detection was done at 245 nm. Analysis of our results shows that 77.7% of the samples did not comply with the visual inspection test requirements, 2.1% did not pass the mass variation test, 24.3% of the sample batches didn’t comply with the disintegration test requirements. In addition none of these uncomply batches passed the dissolution test, even if the identification test indicated that all samples contained paracetamol. None contained 4-NP (acceptance limit < 0.05% m/m;BP), while 3 of 94 samples contained 4-AP but within acceptance limit (4-AP < 0.1% m/m;BP). As for the paracetamol assay, 80.9% complied with the specifications of the pharmacopoeias taken as reference (90% - 110%;USP). Further, broader studies should be conducted according to the same rules of good practice for a more comprehensive analysis of the situation. Generally the quality control of paracetamol in most African countries, particularly in Benin, is based on pharmacotechnical tests and paracetamol assay. This work, in addition to the usual tests, showed the importance to search for paracetamol and other drugs’ impurities during their routine quality control.

关键词： Quality Control Substandard Medicines Paracetamol P-Aminophenol P-Nitrophenol Benin

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