Development and validation of a liquid chromatographic method for the analysis of capreomycin sulfate and its related substances

被引:9
|
作者
Mallampati, Swapna [1 ]
Huang, Shan [1 ]
Ashenafi, Dunge [1 ]
Van Hemelrijck, Elise [1 ]
Hoogmartens, Jos [1 ]
Adams, Erwin [1 ]
机构
[1] Katholieke Univ Leuven, Lab Pharmaceut Anal, O&N 2, B-3000 Louvain, Belgium
关键词
Capreomycin sulfate; Impurities; LC;
D O I
10.1016/j.chroma.2009.01.031
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A gradient LC method for the analysis of capreomycin sulfate and its related substances was developed. The chromatographic conditions include the use of a Hypersil base deactivated C-18 (250 mm x 4.6 mm, 5 mu m) column maintained at 25 degrees C, a mobile phase containing aceronitrile, phosphate buffer pH 2.3 and 0.025 M hexanesulfonate at a flow rate of 1.0 mL/min and UV detection performed at 268 nm. Good separation of the four active components of capreomycin and eleven unknown impurities was achieved. A system suitability test to check the quality of the separation is specified. The method shows good repeatability, linearity and robustness. (c) 2009 Elsevier B.V. All rights reserved.
引用
收藏
页码:2449 / 2455
页数:7
相关论文
共 50 条
  • [41] Development and validation of a reversed-phase high-performance liquid chromatographic method for the quantitation and stability of α-lipoic acid in cosmetic creams
    Papageorgiou, S.
    Varvaresou, A.
    Panderi, I.
    Giannakou, M.
    Spiliopoulou, C.
    Athanaselis, S.
    INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, 2020, 42 (03) : 221 - 228
  • [42] Development and validation of an HPLC assay for fentanyl and related substances in fentanyl citrate injection, USP
    Lambropoulos, J
    Spanos, GA
    Lazaridis, NV
    Ingallinera, TS
    Rodriguez, VK
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1999, 20 (04) : 705 - 716
  • [43] Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase
    Tzanavaras, Paraskevas D.
    CENTRAL EUROPEAN JOURNAL OF CHEMISTRY, 2011, 9 (03): : 446 - 452
  • [44] Validation and application of a liquid chromatographic-mass spectrometric method for determination of artesunate in pharmaceutical samples
    Lindegardh, N.
    Dondorp, A. M.
    Singhasivanon, P.
    White, N. J.
    Day, N. P. J.
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2007, 45 (01) : 149 - 153
  • [45] Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances
    Orlandini, Serena
    Pasquini, Benedetta
    Gotti, Roberto
    Giuffrida, Alessandro
    Paternostro, Ferdinando
    Furlanetto, Sandra
    ELECTROPHORESIS, 2014, 35 (17) : 2538 - 2545
  • [46] Simultaneous Analysis of Ipratropium Bromide and its Related Substances Using HPLC
    Li, Jiankun
    Li, Guoxin
    Zhao, Lili
    Wang, Hairong
    Sun, Chujun
    CURRENT PHARMACEUTICAL ANALYSIS, 2021, 17 (02) : 293 - 300
  • [47] Development and validation of a novel LC/ELSD method for the quantitation of gentamicin sulfate components in pharmaceuticals
    Megoulas, NC
    Koupparis, MA
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2004, 36 (01) : 73 - 79
  • [48] Development and Validation of Liquid Chromatography Method for the Determination and Quantification of Impurities in Imiquimod
    Hussain, Sayyed
    Shaikh, Tabrez
    Farooqui, Mazhar
    BRITISH JOURNAL OF PHARMACEUTICAL RESEARCH, 2016, 13 (01):
  • [49] Liquid chromatographic validation of a quantitation method for phytoestrogens, biochanin-A, coumestrol, daidzein, formononetin, and genistein, in lucerne
    Martin, Luisa M.
    Castilho, M. Conceicao
    Silveira, M. Irene
    JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, 2006, 29 (19) : 2875 - 2884
  • [50] Development and validation of a stability-indicating RP-HPLC method for the identification, determination of related substances and assay of dimethyl fumarate in drug substance
    Kommareddy, S.
    Nigam, R. S.
    Kumar, S.
    ANNALES PHARMACEUTIQUES FRANCAISES, 2021, 79 (02): : 179 - 193