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西安医科大学学报(英文版)
西安医科大学学报(英文版)

郑南宁

季刊

1671-8267

xyluck2003@126.com

029-82655412

710061

西安市雁塔西路76号

西安医科大学学报(英文版)/Journal Academic Journal of Xi'an Jiaotong University(English EditionCSCD
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    Simultaneous determination of telmisartan and amlodipine in human plasma by LC-MS]MS and its application in a human pharmacokinetic study

    Vasu Babu RaviJaswanth Kumar InamaduguNageswara Rao PilliVudagandla Sreenivasulu...
    319-326页
    查看更多>>摘要：A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma. Carbamazepine was used as an internal standard. Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis HLB 1 cm3 (30 mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C18 column (50mm × 4.6mm, 5 gm) using a mixture of acetonitrile -5 mM ammonium acetate buffer (pH-4.0) (50:50, v/v) as the mobile phase at a flow rate of 0.8mL/min. The calibration curve obtained was linear (r_〉0.99) over the concentration range of 2.01-400.06 ng/mL for telmisartan and 0.05 -10.01 ng/mL for amlodipine. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

    LC-MS/MS高效液相色谱法氨氯地平替米沙坦人血浆药代动力学同时测定应用

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    Authentication and distinction of Shenmai injection with HPLC fingerprint analysis assisted by pattern recognition techniques

    Xue-Feng LuKai-Shun BiXu ZhaoXiao-Hui Chen...
    327-333页
    查看更多>>摘要：In this paper, the feasibility and advantages of employing high performance liquid chromatographic (HPLC) fingerprints combined with pattern recognition techniques for quality control of Shenmai injection were investigated and demonstrated. The Similarity Evaluation System was employed to evaluate the similarities of samples of Shenmai injection, and the HPLC generated chromatographic data were analyzed using hierarchical clustering analysis (HCA) and soft independent modeling of class analogy (SIMCA). Consistent results were obtained to show that the authentic samples and the blended samples were successfully classified by SIMCA, which could be applied to accurate discrimination and quality control of Shenmai injection. Furthermore, samples could also be grouped in accordance with manufacturers. Our results revealed that the developed method has potential perspective for the original discrimination and quality control of Shenmai injection.

    参麦注射液指纹图谱分析模式识别技术HPLC认证高效液相色谱质量控制评价系统

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    Kinetic spectrophotometric method for determination of amlodipine besylate in its pharmaceutical tablets

    Ashraf M. MahmoudHanaa M. Abdel-WadoodNiveen A. Mohamed
    334-341页
    查看更多>>摘要：A simple and sensitive kinetic spectrophotometric method has been developed and validated for determination of amlodipine besylate (AML). The method was based on the condensation reaction of AML with 7-chloro-4-nitro-2,1,3-benzoxadiazole in an alkaline buffer (pH 8.6) producing a highly colored product. The color development was monitored spectrophometrically at the maximum absorption λmax 470 nm. The factors affecting the reaction were studied and the conditions were optimized. The stoichiometry of the reaction was determined, and the reaction pathway was postulated. Moreover, both the activation energy and the specific rate constant (at 70 ℃) of the reaction were found to be 6.74 kcal mole-1 and 3.58 s -1, respectively. The initial rate and fixed time methods were utilized for constructing the calibration graphs lbr the determination of AML concentration. Under the optimum reaction conditions, the limits of detection and quantification were 0.35 and 1.05 ug/mL, respectively. The precision of the method was satisfactory; the relative standard deviations were 0.85-1.76%. The proposed method was successfully applied to the analysis of AML in its pure form and tablets with good accuracy; the recovery percentages ranged from 99.55 ± 1.69% to 100.65 ±1.48%. The results were compared with that of the reported method.

    分光光度法测定氨氯地平动力学缩合反应药片最佳反应条件AML彩色显影

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    Bio-analytical method development and validation of Rasagiline by high performance liquid chromatography tandem mass spectrometry detection and its application to pharmacokinetic study

    Ravi Kumar KondaBabu Rao ChanduB.R. ChallaChandrasekhar B. Kothapalli...
    342-349页
    查看更多>>摘要：The most suitable bio-analytical method based on liquid liquid extraction has been developed and validated for quantification of Rasagiline in human plasma. Rasagiline-13C3 mesylate was used as an internal standard for Rasagiline. Zorbax Eclipse Plus C18 (2.1 mm × 50 mm, 3.5 um) column provided chromatographic separation of analyte followed by detection with mass spectrometry. The method involved simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode using an API-4000 system. The lotal run time was 3.0 min. The proposed method has been validated with the linear range of 5 12000 pg/mL for Rasagiline. The intra-run and inter-run precision values were within 1.3% 2.9% and 1.6% 2.2% respectively for Rasagiline. The overall recovery for Rasagiline and Rasagiline-13C3 mesylate analog was 96.9% and 96.7% respectively. This validated method was successfully applied to the bioequivalence and pharmacokinetic study of human volunteers under fasting condition.

    药代动力学生物分析法质谱检测高效液相色谱串联质谱法验证开发应用

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    Normal and reverse flow injection-spectrophotometric determination of thiamine hydrochloride in pharmaceutical preparations using diazotized metoclopramide

    MouayedQ. AI AbachiHind Hadi
    350-355页
    查看更多>>摘要：Simple and sensitive normal and reverse flow injection methods for spectrophotometric determination of thiamine hydrochloride (THC) at the microgram level were proposed and optimized. Both methods are based on the reaction between THC and diazotized metoclopramide in alkaline medium. Beer's law was obeyed over the range of 10 300 and 2-90 ug/mL, the limits of detection were 2.118 and 0.839 ug/mL and the sampling rates were 80 and 95 injections per hour for normal and reverse flow injection methods respectively. The application of both methods to commercially available pharmaceuticals produced acceptable results. The flow system is suitable for application in quality control processes.

    反向流动注射分光光度法测定盐酸硫胺胃复安重氮化药物制剂质量控制过程碱性介质

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    Analysis of arecoline in Semen Arecae decoction pieces by microchip capillary electrophoresis with contactless conductivity detection

    Zi-You CaiYong-Chong LiLi-Hua LiZuan-Guang Chen...
    356-360页
    查看更多>>摘要：A new method for the determination of arecoline in Semen Arecae decoction pieces by microchip capillary electrophoresis with contactless conductivity detection (MCE-CCD) was proposed. The effects of various electrophoretic operating parameters on the analysis of arecoline were studied. Under the optimal conditions, arecoline was rapidly separated and detected in 1 rain with good linearity over the concentration range of 20 1500 uM (r2=0.9991) and the detection limit of 5 uM (S/N=3). The method was used for the analysis of arecoline satisfactorily with a recovery of 96.8 -104%.

    芯片毛细管电泳非接触电导检测槟榔碱检测分析饮片操作参数最佳条件快速分离

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    Pre-concentration and determination of amitriptyline residues in waste water by ionic liquid based immersed droplet microextraction and HPLC

    M.T. Hamed MosavianZ. Es＇haghiN. RazaviS. Banihashemi...
    361-365页
    查看更多>>摘要：This paper describes a new approach for the determination of amitriptyline in wastewater by ionic liquid based immersed droplet microextraction (IL-IDME) prior to highperformance liquid chromatography with ultraviolet detection. 1-Hexyl-3-methylimidazolium hexafluorophosphate ([C6MIM][PF6]) was used as an ionic liquid. Various factors that affect extraction, such as volume of ionic liquid, stirring rate, extraction time, pH of the aqueous solution and salting effect, were optimized. The optimal conditions were as follows: microextraction time, 10 min; stirring rate, 720 rpm; pH, 11; ionic drop volume, 100 uL; and no sodium chloride addition. In quantitative experiments the method showed linearity in a range from 0.01 to 10 ug/mL, a limit of detection of 0.004 ug/mL and an excellent pre-concentration factor (PF) of 1100. Finally, the method was successfully applied to the determination of amitriptyline in the hospital wastewater samples.

    高效液相色谱法离子性液体残留量测定萃取时间液体浸泡液滴废水预浓缩

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    Development and validation of a RP-HPLC method for the simultaneous determination of Embelin, Rottlerin and EUagic acid in Vidangadi churna

    Rakesh K. PatelVishal R. PatelMadhavi G. Patel
    366-371页
    查看更多>>摘要：Vidangadi churna is a popular Ayurvedic formulation described in the chapter Krimicikitsa of the Ayurvedic literature Cakradatta for the treatment of Krimiroga. The preparation is a composite mixture of the fine powder of fruits of Vidang (Embelia ribs), glandular trichomes of the fruits of Kamala (Mallotus philippensis), mature fruits of Harde (Terminalia chehula), Saindhava and Yavakshara. The use of reversed phase C18 column eluted with gradient mobile phase of acetonitrile and water enabled the efficient separation of the chemical markers in 22 rain. Validation of the method was performed in order to demonstrate its selectivity, accuracy, precision, repeatability and recovery. All calibration curves showed good linear correlation coefficients (r2〉0.995) within the tested ranges. Three markers in Vidangadi churna were quantitied with respect to Embelin (0.647%, w/w), Rottlerin (4.419%, w/w), and Ellagic acid (0.459%, w/w). lntraand inter-day RSDs of retention times and peak areas were less than 3.12%. The recoveries were between 99.66% and 102.33%. In conclusion, a method has been developed for the simultaneous quantification of three markers in Vidangadi churna. The RP-HPLC method was simple, precise and accurate and can be used for the quality control of the raw materials as well as formulations.

    RP-HPLC法测定方法验证开发线性相关系数相对标准偏差HPLC方法标记物

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    Impurity profiling and in-process testing of drugs for injection by fast liquid chromatography

    Marie-Josee RocheleauElaine LaroucheCristina SalamuMihaela Curca...
    372-377页
    查看更多>>摘要：Liquid chromatography (LC) is considered by many as a mature technique. Nonetheless, LC technology continues to evolve driven by the need for high-throughput and high-resolution analyses. Over the past several years, small particle size packing materials have been introduced by several column manufacturers to enable fast and efficient LC separations. Several examples of pharmaceutical analyses, including impurity profiling of taxanes and atracurium besylate, in-process testing of peptides in injectable dosage form, using sub-2 um column technology are presented in this paper, demonstrating some of the capabilities and limitations of the technology.

    液相色谱分离测试过程杂质分析注射用药物高分辨率包装材料氨氯地平

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    Determination of metronidazole in a rat stomach by HPLC for obtaining basic data of the eradication therapy of Helicobacter pylori

    Mai KuboderaTadakazu TokumuraYoshiharu Machida
    378-381页
    查看更多>>摘要：In the eradication therapy of Helicobacter pylori changes of antibiotics as these concentrations or amount in the stomach after oral administration were not clear. A simple and accurate method for determining the concentration of metronidazole (MTZ) in homogenate of rat stomach was developed in order to obtain basic data to design a pharmaceutical preparation having targeting ability to the surface of gastric-mucosa. This method included a deproteinization process by methanol, separation with reversed-phase high-performance liquid chromatography, and detection with an ultraviolet wavelength of 370 nm. Regression analysis showed that the method was linear over a standard curve nmge from 5 ug/mL to 2000 g/mL. The inter-day precision and accuracy values between thc ranges were 5.0% or better and -7.5 to 5.2%, respectively. The newly developed method was applied to an analysis of gastric samples after oral administration of MTZ at a dose of 5 mg/kg. It was found that the residual MTZ in the stomach was determined within 5 h after dosing. This method is useful for monitoring MTZ in stomach after its oral administration to rats.

    HPLC测定幽门螺杆菌甲硝唑大鼠治疗根除胃口服给药

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