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目的建立测定富马酸酮替芬滴鼻液中富马酸酮替芬含量的反相高效液相色谱法。方法采用Agilent SB-C18色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(50∶50),流速1.0 mL/min,测定波长301 nm,柱温为室温。结果富马酸酮替芬进样量在0.020 26~1.013 0μg范围内与峰面积线性关系良好,r=0.999 9(n=5);平均加样回收率为99.51%,RSD为1.56%(n=9)。结论所用方法操作简便、准确可靠,可作为富马酸酮替芬滴鼻液的质量控制方法。 相似文献
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目的建立高效液相色谱法测定富马酸酮替芬片的含量及含量均匀度的方法。方法采用Shim-pack VP-ODS C18柱(150mm×4.6mm,5μm);以乙腈-0.04mol.L-1磷酸二氢钾(28∶72)为流动相,磷酸调pH 3.5;流速1mL.min-1;检测波长300nm;柱温为30℃。结果富马酸酮替芬在9.75~97.50μg.mL-1的范围内线性关系良好(r=0.999 6),平均加样回收率为99.3%,RSD为0.4%(n=6)。结论高效液相法简便、快速,重复性良好。 相似文献
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目的:建立以毛细管电泳法测定富马酸比索洛尔片中主药含量的方法。方法:采用熔融石英毛细管柱,运行缓冲液为50mmol·L-1三羟甲基氨基甲烷-磷酸盐缓冲液(pH3.85) ,电压进样为10kV×5s ,工作电压为20kV,柱温为25℃,检测波长为273nm。结果:富马酸比索洛尔检测浓度的线性范围为0.025~0.250mg·mL-1(r=0.999 4) ;平均加样回收率为98.96%(RSD=0.84%)。结论:本方法简便、准确、快速、重现性好,可用于该制剂的质量控制。 相似文献
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富马酸酮替芬滴眼剂稳定性考察 总被引:1,自引:0,他引:1
通过对不同pH值富马酸酮替芬滴眼剂的制备、及光、热对不同pH值滴眼剂稳定性影响的比较,发现富马酸酮替芬滴眼剂稳定性受pH值影响。 相似文献
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目的 研究富马酸酮替芬颗粒与富马酸酮替芬片(均为平喘药)的相对生物利用度,评价2者的生物等效性.方法 采用双周期自身交叉试验设计,单剂量口服给药.24例健康男性受试者分别单剂量口服受试制剂和参比制剂,血浆样品采用高效液相色谱串联质谱法检测.结果 受试制剂富马酸酮替芬颗粒及参比制剂富马酸酮替芬片的主要药代动力学参数:Cmax分别为(247.76±99.61),(229.24±96.44)ng·L-1;tmax分别为(2.38±0.97),(2.46±1.14)h;t1/2分别为(14.85±5.76),(14.69±7.91) h;AUC0-tn分别为(2641.07±1025.19),(2764.19±1231.50) ng·L-1·h;AUC0-∞分别为(3192.01±1272.20),(3431.11±1902.72) ng·L-1·h;受试制剂富马酸酮替芬颗粒的相对生物利用度F0-tn、F0-∞分别为(100.08±21.81)%,(102.75±30.33)%.结论 受试制剂和参比制剂具有生物等效性. 相似文献
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目的:建立分离舒必利消旋体并准确检测左舒必利片剂中主药含量的毛细管电泳法。方法:采用熔融石英毛细管柱(50μm×31 cm,有效长度为21 cm),以含2%高磺化α-环糊精的20 mmol.L-1柠檬酸钠缓冲溶液为运行缓冲液,检测波长为214 nm,分离电压为-10 kV。结果:实现了左舒必利和右舒必利的基线分离,左舒必利在0.001~0.1 mg.mL-1范围内线形关系良好,用建立的方法检测3批左舒必利片标示含量分别为97.08%,98.77%,98.78%。结论:本方法灵敏度高,简便快捷,适用于左舒必利片剂的含量测定和质量控制。 相似文献
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毛细管气相色谱法测定富马酸福莫特罗中的残留溶剂 总被引:1,自引:0,他引:1
目的:建立毛细管气相色谱法检测富马酸福莫特罗中乙醇、异丙醇、二氯甲烷、乙酸乙酯和N,N-二甲基甲酰胺的方法。方法:采用DB-624毛细管色谱柱;柱温采用程序升温的方法;载气为氮气;FID检测器。结果:本色谱条件下,乙醇、异丙醇、二氯甲烷、乙酸乙酯和N,N-二甲基甲酰胺线性关系良好,相关系数均在0.999 6以上,平均回收率分别为101.0%、100.9%、102.8%、97.1%及100.5%。检出限分别为5、5、3、5及1.8μg/ml。结论:本法灵敏、准确,适用于富马酸福莫特罗残留溶剂的检测。 相似文献
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A capillary electrophoretic method was developed for the determination of loratadine in pharmaceutical formulations. Capillary zone electrophoresis (CZE) separation and UV absorbance photometric detection were carried out in a 160 mm capillary tube with a 300 microm internal diameter, hydrodynamically (membrane) closed. The influences of pH, carrier cation and counter ion on the migration parameters of loratadine were studied and the following conditions were selected: 24 mmol/l glycine as a carrier cation, 1.6 mmol/l citric acid and 84 mmol/l acetic acid as counter ions at pH 3.2, 100 microA and 25 degrees C. The proposed electrophoretic method was successfully validated. It was convenient for the sensitive, simple, rapid and highly reproducible assay of loratadine. The determination of loratadine in tablet forms was demonstrated as an application of the method. CZE analysis was completed within 6 min. The detection limit of loratadine was 1.96 micro/mol/l at a 240 nm detection wavelength and the relative standard deviation for its determination was 0.6% for migration time and 1.1% for peak area. CZE in a hydrodynamically closed separation system, used for the first time for the analysis of loratadine, should also be convenient for complex biological sample applications, as it is easily combinable online with the purification CE modes (e.g. ITP). 相似文献
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目的:建立毛细管电泳法测定盐酸倍他洛尔片的含量。方法:采用熔融石英毛细管柱,37cm×75μm(有效长度30cm);运行缓冲液:30mmol·L~(-1)醋酸盐缓冲液(pH4.0);电压进样10kV×5s;工作电压20kV;柱温25℃;检测波长273nm。结果:盐酸倍他洛尔浓度在0.05~0.30mg·mL~(-1)的范围内线性关系良好(r=0.9995,n=6),平均加样回收率为99.2%,RSD为0.63%。结论:本方法简便、准确、快速,重复性好,可用于盐酸倍他洛尔片的含量测定。 相似文献
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目的:在2008年国家食品药品监督管理局颁布的毛细管电泳法分析肝素钠杂质的补充检验方法的基础上优化毛细管电泳色谱条件,对全国评价性抽验肝素钠注射液样品进行测定。方法:采用毛细管电泳法,缓冲液为pH 3.0的400 mmol.L-1三羟甲基氨基甲烷(Tris)溶液;分离电压为-25 kV;检测波长为200 nm;进样压力3.447 kPa,进样时间为4 s;毛细管温度:25℃。结果:肝素主峰与多硫酸软骨素峰峰之间分离度为1.0,与硫酸皮肤素之间分离度为2.0,10批供试品的杂质含量结果与离子色谱法结果基本一致。结论:优化后的色谱条件使肝素与硫酸皮肤素、多硫酸软骨素的分离度增加,该方法使肝素钠样品中的杂质定性、定量更为准确。 相似文献
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Fernández H Rupérez FJ Barbas C 《Journal of pharmaceutical and biomedical analysis》2003,31(3):499-506
While HPLC has traditionally been the method of choice for purity determination of pharmaceutical substances, capillary electrophoresis (CE) offers a different selectivity and hence it is a complementary technique to HPLC. Loratadine, an antihistamine, could include in its raw material seven impurities that ought to be separated, identified and quantified for drug development and quality control. As a complementary tool for undoubtful identification, a CE method has been developed. The separation was carried out with an uncoated fused-silica capillary (57 cm x 50 microm ID) and was operated at 20 kV potential. Temperature was maintained at 25 degrees C. The final separation buffer was prepared with 100 mM H(3)PO(4) made up to pH 2.5 with NaOH and with 10% acetonitrile added (v/v). Impurities can be detected at the 0.1% level of the active and validation parameters for linearity accuracy and precision are adequate for all the analytes and that permits to consider the method reliable and suitable for application to long-term stability and purity studies. 相似文献
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目的:建立测定还原型谷胱甘肽中的有关物质的毛细管区带电泳方法。方法:采用未涂层熔融石英毛细管(60 cm×75μm,有效长度50 cm);以50 mmol.L-1的磷酸二氢钠溶液(pH1.8),添加10%甲醇为运行缓冲液;运行电压为20 kV,柱温25℃;检测波长200 nm;压力进样3.45 kPa。结果:还原型谷胱甘肽中4个已知杂质半胱氨酰甘氨酸、g-谷氨酰半胱氨酸、氧化型谷胱甘肽和半胱氨酸,杂质峰/内标峰校正峰面积精密度(RSD)分别为0.57%,1.24%,0.58%,1.56%(n=5),最低检测浓度分别为0.0263,0.0234,0.0099,0.0257 mg.mL-1;在0.005~0.2 mg.mL-1范围内与各杂质峰/内标峰校正峰面积呈现良好线性(r分别为0.9996,0.9992,0.9998,0.9983);结论:方法快速、简单且准确,可用于还原型谷胱甘肽中有关物质的测定。 相似文献