DEVELOPMENT AND VALIDATION OF METHOD BY HPLC TECHNIQUES

被引:1
作者
Kaur, Amandeep [1 ]
Gupta, Monika [2 ]
机构
[1] ASBASJSM Coll Pharm, Dept Pharmaceut Chem, Bela 140111, Robar, India
[2] ASBASJSM Coll Pharm, Pharmaceut Chem, Bela 140111, Robar, India
来源
INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2018年 / 5卷 / 07期
关键词
Introduction; Method development; Steps for HPLC method development; Method validation; Advantages of method validation and Parameters for validation;
D O I
10.5281/zenodo.1325897
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The primary focus of the review article is on general approaches and considerations toward development of chromatographic methods for separation, identification, and quantification of compounds, which may be applied within the various functions in the drug development continuum. This article also discusses the issues and parameters that must be considered in the validation of analytical methods. At the end of the review, a scope of the present research study is covered.
引用
收藏
页码:7057 / 7065
页数:9
相关论文
共 37 条
  • [1] [Anonymous], 2000, GDA GUID IND AN PROC
  • [2] Chan CC, 2004, ANAL METHOD VALIDATI, V1
  • [3] The value of analytical assays that are stability-indicating
    Chan, ECY
    Wee, PY
    Ho, PC
    [J]. CLINICA CHIMICA ACTA, 1999, 288 (1-2) : 47 - 53
  • [4] Impurity profile study of lopinavir and validation of HPLC method for the determination of related substances in lopinavir drug substance
    Chitturi, Sreenivasa Rao
    Bharathi, Ch.
    Reddy, A. V. Raghava
    Reddy, K. Chandrasekhar
    Sharma, Hemant Kumar
    Handa, Vijay Kumar
    Dandala, Ramesh
    Bindu, V. Hima
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2008, 48 (05) : 1430 - 1440
  • [5] Development and application of a validated HPLC method for the analysis of dissolution samples of levothyroxine sodium drug products
    Collier, J. W.
    Shah, R. B.
    Bryant, A. R.
    Habib, M. J.
    Khan, M. A.
    Faustino, P. J.
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2011, 54 (03) : 433 - 438
  • [6] Development of a sensitive HPLC method to measure in vitro permeability of E- and Z-isomeric forms of thiosemicarbazones in Caco-2 monolayers
    Debebe, Zufan
    Nekhai, Sergei
    Ashenafi, Meseret
    Lovejoy, David B.
    Kalinowski, Danuta S.
    Gordeuk, Victor R.
    Byrnes, W. Malcolm
    Richardson, Des R.
    Karla, Pradeep K.
    [J]. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2012, 906 : 25 - 32
  • [7] Validation of a HPLC method for the determination of p-nitrophenol hydroxylase activity in rat hepatic microsomes
    Elbarbry, F
    Wilby, K
    Alcorn, J
    [J]. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2006, 834 (1-2): : 199 - 203
  • [8] European-commission, SANCO102322006 EUR C
  • [9] Optimization and validation of a SPE-HPLC-PDA-fluorescence method for the simultaneous determination of drugs used in combined cardiovascular therapy in human plasma
    Gonzalez, Oskar
    Iriarte, Gorka
    Ferreiros, Nerea
    Itxaso Maguregui, Miren
    Maria Alonso, Rosa
    Maria Jimenez, Rosa
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2009, 50 (04) : 630 - 639
  • [10] Guidelines for in-house validation of analytical methods for pesticide residues in food and animal feeds
    Hill, ARC
    Reynolds, SL
    [J]. ANALYST, 1999, 124 (06) : 953 - 958