A sensitive and specific high performance liquid chromatography （HPLC） method was developed and validated for the simultaneous determination of metformin hydrochloride （HCI） in human plasma. The HPLC method consis...A sensitive and specific high performance liquid chromatography （HPLC） method was developed and validated for the simultaneous determination of metformin hydrochloride （HCI） in human plasma. The HPLC method consists of isocratic eluation with a mixture of 60% buffer （10 mM sodium dihyrogenphosphate-10 mM sodium dodecyl sulphate） and 40% acetonitrile with final pH 7.0 with flow rate of 1.0 mL/min on a Kromasil~ Akzo Nobel RP-18 （4.6 mm ID ~ 250 mm, 5 ~tm） column at an ambient temperature. Photo diode array detection was performed in program mode at 234 rim. The analyte and diazepam as internal standard （IS） were extracted from plasma using 10% trichloroacetic acid. The assay was linear over the therapeutic concentration range of 20-2,500 ng/mL for metformin HCI with correlation coefficient of r = 0.9999. Limit of quantitation was 20 ng/mL. The results obtained for intraJinter day accuracy and precision complied very well with the generally accepted criteria for bio-analytical assay. The method was applied to bioequivalence （BE） study of metformin HCI in healthy Indonesian volunteers after treatment with 750 mg XR metformin HCI. This BE study shows that the two formulations are equivalent so that they were therapeutically interchangeable for each other.展开更多
文摘目的:研究血浆硫氧还蛋白还原酶(thioredoxin reductase,TrxR)在乳腺癌组织中的表达及其临床价值。方法:乳腺癌患者80例设为乳腺癌组,良性乳腺肿瘤患者48例设为良性对照组,50例健康体检人员设为正常对照组。采用酶联免疫吸附试验检测血浆TrxR水平,化学发光法检测血清癌抗原(carcinoma antigen 153,CA153)水平。比较3组血浆TrxR水平,分析TrxR水平与乳腺癌患者临床病理参数的关系,采用Spearman相关性分析血浆TrxR与血清CA153的相关性,受试者工作特征曲线(receiver operating characteristic curve,ROC)评估血浆TrxR、血清CA153对乳腺癌的诊断价值,比较乳腺癌患者治疗前后TrxR水平的变化。结果:乳腺癌组血浆TrxR水平明显高于良性对照组及正常对照组,良性对照组血浆TrxR水平明显高于正常对照组,差异均有统计学意义(P<0.05)。组织学分级Ⅱ~Ⅲ级乳腺癌患者血浆TrxR水平明显高于Ⅰ级患者,发生淋巴结转移患者血浆TrxR水平明显高于无淋巴结转移患者,TNM分期Ⅲ~Ⅳ期患者血浆TrxR水平明显高于Ⅰ~Ⅱ期患者,差异均有统计学意义(P<0.05)。Spearman相关性分析显示,血浆TrxR和血清CA153具有一定的相关性(r=0.3805,P<0.05)。ROC曲线分析显示,TrxR诊断乳腺癌的敏感度为84.0%,特异度为75.0%,曲线下面积(area under the curve,AUC)为0.8470;CA153诊断乳腺癌的敏感度为70.0%,特异度为77.5%,AUC为0.7815。72例Ⅰ~Ⅲ期乳腺癌患者接受手术治疗及术后辅助治疗,治疗后2个月乳腺癌患者TrxR水平较治疗前明显下降,差异有统计学意义(P<0.05)。结论:血浆TrxR可能成为有效的乳腺癌诊断指标,其在评估乳腺癌病情恶化程度、预测未来发展趋势等方面具有重要的临床意义。
文摘A sensitive and specific high performance liquid chromatography （HPLC） method was developed and validated for the simultaneous determination of metformin hydrochloride （HCI） in human plasma. The HPLC method consists of isocratic eluation with a mixture of 60% buffer （10 mM sodium dihyrogenphosphate-10 mM sodium dodecyl sulphate） and 40% acetonitrile with final pH 7.0 with flow rate of 1.0 mL/min on a Kromasil~ Akzo Nobel RP-18 （4.6 mm ID ~ 250 mm, 5 ~tm） column at an ambient temperature. Photo diode array detection was performed in program mode at 234 rim. The analyte and diazepam as internal standard （IS） were extracted from plasma using 10% trichloroacetic acid. The assay was linear over the therapeutic concentration range of 20-2,500 ng/mL for metformin HCI with correlation coefficient of r = 0.9999. Limit of quantitation was 20 ng/mL. The results obtained for intraJinter day accuracy and precision complied very well with the generally accepted criteria for bio-analytical assay. The method was applied to bioequivalence （BE） study of metformin HCI in healthy Indonesian volunteers after treatment with 750 mg XR metformin HCI. This BE study shows that the two formulations are equivalent so that they were therapeutically interchangeable for each other.
