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81.
目的改进《中国药典》2005年版中头孢哌酮聚合物的测定方法。方法采用Shodex SUGAR KS-802凝胶柱,流动相A为0.5 mol.L-1磷酸盐缓冲液,流动相B为水,柱温为35℃。结果头孢哌酮Kav=4.2,聚合物与头孢哌酮峰得到完全分离。结论改进后的方法克服了药典方法测定聚合物分离度不佳的弱点,测定结果更为准确可靠。 相似文献
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Ashraf-Khorassani M Taylor LT Williams DG Roston DA Catalano TT 《Journal of pharmaceutical and biomedical analysis》2001,26(5-6):725-738
Assay development, assay validation, and documentation are reported here for a single packed column pressurized fluid chromatographic/ultraviolet (UV) method that provides: (1) simultaneous detection and quantification for the chiral drug, the chiral impurity and seven achiral impurities; and (2) a Fourier transform infrared (FT-IR) spectrometric identification test result for the Searle drug substance sample, xemilofiban. The separation is achieved in less than 30 min with three columns in tandem and a gradient of CO2–CH3OH. The post-column flow is split between UV (assay) and FT-IR (identification). Precision and accuracy are consistent within figures of merit obtained by liquid chromatographic-ultraviolet assays on analogous drug substances. The reported procedure combines three typical drug substance tests into one test (e.g. chiral impurities, achiral impurities, and infrared identification). 相似文献
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Amphoacetates are organic compounds used in many industrial applications and in cosmetic formulations for the skin, hair and mucosa, as surfactants, mild foaming and cleansing agents in concentrations ranging from 0.1% to 50%. Despite the fact that they have been in use for many years, cases of contact allergy to them are extremely rare. We describe 4 patients who developed an eczematous reaction after use of detergents containing amphoacetates. Patch testing showed positive reactions to sodium lauroamphoacetate (Miranol HM Special, Rhodia, England) as is or diluted at decreasing concentration (10%, 5% and 1%) in water and to aminoethylethanolamine (AEE) at the concentration of 1% in various vehicles (ethanol, acetone, and sodium laurylethersulfate 1% aqueous solution) and at decreasing concentrations ranging from 1% to 0.005% in water. AEE is one of the reagents used in the synthesis of amphoacetates. This molecule, that is structurally an ethylenediamine derivative, has sensitizing power and is reported as a cause of occupational contact allergy in cable jointers. Combined eczematous reactions to AEE and sodium lauroamphoacetate can be consequent to the presence of the former substance as an impurity in amphoacetates-containing products, as demonstrated by ion chromatography-mass spectrometry analysis. 相似文献
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目的建立新的高效液相法测定消旋卡多曲的含量及其杂质。方法采用C18色谱柱(4.60cm×25 cm),以乙腈磷酸二氢钾溶液(取磷酸二氢钾1g,加85%磷酸1mL,加水稀释至1000 mL)(70∶30)为流动相;检测波长为210 nm。结果含量线性范围为0.08~0.24 mg·mL-1,回归方程为Y=15847X+3873(r=0.9997),已知杂质benzylthiorphan disulphide线性范围为2.40~21.6μg·mL-1,回归方程为Y=1826X+46(r=0.9999),其最低检测浓度为1μg·mL-1,加样平均回收率为100.0%(n=6)。结论方法简便、快速准确。 相似文献
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目的 建立高效液相色谱-四级杆-静电场轨道阱高分辨质谱(HPLC-Q-Exactive Orbitrap-MS)联用法对阿昔洛韦片及其强制降解试验样品中的杂质进行结构分析。方法 采用Waters Xbridge BEH Shield RP18(4.6 mm×250 mm,5μm)色谱柱,以10 mmol·L–1甲酸铵溶液(含0.15%甲酸)为流动相A,以10 mmol·L–1甲酸铵溶液(含0.15%甲酸)-乙腈(50∶50)为流动相B,进行梯度洗脱,检测波长为254 nm,对阿昔洛韦片及其强制降解试验样品中的杂质进行分离,再采用QExactive Orbitrap-MS测定各杂质一级精确分子量及二级碎片离子,并进行结构鉴定。结果 阿昔洛韦及其杂质均分离良好,检测并鉴定出阿昔洛韦片及其强制降解试验样品中8个含量>0.1%的主要杂质,其中4个为欧洲药典10.0规定的已知杂质,而其他杂质均未见报道。结论 建立的液质联用技术能有效鉴定阿昔洛韦片的杂质,能够为其生产工艺的优化和质量控制提供参考。 相似文献
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盐酸头孢他美酯中有关物质测定研究 总被引:3,自引:0,他引:3
王建 《中国医药工业杂志》2000,31(7):308-310
用高效液相色谱法测定盐酸头孢他美酯中的有关物质。对方法专属性、杂质峰归属、线性关系、灵敏度、重复性进行了系统的研究。本法对杂质能有效分离,线性关系r=0.9999,最低检测浓度为0.1ug/ml,重复性RSD0.83%。 相似文献
89.
Identification,isolation, and synthesis of seven novel impurities of anti‐diabetic drug Repaglinide 下载免费PDF全文
《Drug testing and analysis》2018,10(1):212-221
Seven unknown impurities in Repaglinide bulk drug batches at below 0.1% (ranging from 0.05 to 0.10%) were detected by an ultra‐performance liquid chromatographic (UPLC) method. These impurities were isolated from the crude sample of Repaglinide using preparative high performance liquid chromatography (prep‐HPLC). Based on liquid chromatography‐electrospray ionization‐mass spectrometry (LC‐ESI/MS) study, the chemical structures of seven new impurities ( 8 , 9 , 10 , 11 , 13 , 14, and 16 ) were presumed and characterized as 4‐(cyanomethyl)‐2‐ethoxybenzoic acid ( 8) , 4‐(cyanomethyl)‐2‐ethoxy‐N‐(3‐methyl‐1‐(2‐(piperidin‐1‐yl)phenyl)butyl)benzamide ( 9 ), 4‐(2‐amino‐2‐oxoethyl)‐2‐ethoxy‐N‐(3‐methyl‐1‐(2‐(piperidin‐1‐yl)phenyl)butyl) benzamide ( 10 ) and 2‐(3‐ethoxy‐4‐((3‐methyl‐1‐(2‐(piperidin‐1‐yl)phenyl)butyl) carbamoyl) phenyl) acetic acid ( 11) and 4‐(cyanomethyl)‐N‐cyclohexyl‐2‐ethoxybenzamide ( 13) , 2‐(4‐(cyclohexylcarbamoyl)‐3‐ethoxyphenyl) acetic acid ( 14) and N‐cyclohexyl‐4‐(2‐(cyclohexylamino)‐2‐oxoethyl)‐2‐ethoxybenzamide ( 16) . The complete spectral analysis, proton nuclear magnetic resonance (1H NMR), 13C NMR, MS, and infrared (IR) confirmed the proposed chemical structures of impurities. Identification, structural characterization, formation, and their synthesis was first reported in this study. The impurity 11 was crystallized and structure was solved by single crystal X‐ray diffraction. Copyright © 2017 John Wiley & Sons, Ltd. 相似文献
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