Analytical Stability-Indicating Methods for Alogliptin in Tablets by LC-CAD and LC-UV

被引:7
|
作者
Bertol, Charise Dallazem [1 ,2 ]
Friedrich, Maria Tereza [3 ]
Carlos, Graciela [1 ]
Froehlich, Pedro Eduardo [1 ]
机构
[1] Univ Fed Rio Grande do Sul, Fac Farm, Lab Prod Subst Quim Referencia, Ave Ipiranga 2752, BR-90610000 Porto Alegre, RS, Brazil
[2] Univ Passo Fundo, Inst Ciencias Biol, Curso Farm, Lab Controle Qualidade, Campus 1,Km 292,BR 285, BR-99052900 Passo Fundo, RS, Brazil
[3] Univ Passo Fundo, Ctr Pesquisa Alimentacao, Lab Cromatog, Campus 1,Km 292,BR 285, BR-99052900 Passo Fundo, RS, Brazil
关键词
CHARGED-AEROSOL DETECTION; PERFORMANCE LIQUID-CHROMATOGRAPHY; PHARMACEUTICAL ANALYSIS; DETECTOR;
D O I
10.5740/jaoacint.16-0183
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Stability-indicating LC methods using a UV detector and a charged aerosol detector (CAD) simultaneously were validated for the assessment of alogliptin (ALG) in tablets. The analysis was performed on a C-8 column (250 x 4.6 mm, 5 mu m) at a flow of 0.8 mUmin, using acetonitrile-10 mM ammonium acetate buffer (pH 3.5; 90 + 10, v/v) as mobile phase and UV detection at 275 nm. Validation followed the International Conference on Harmonization guidelines. The method was linear over the range of 25-200 mu g/mL. Normality of the residuals showed a normal distribution, no autocorrelation, and homoscedasticity. LODs were 6.25 and 2.65 pg/mL and LOQs were 20.85 and 8.84 mu g/mL for the CAD and the UV detector, respectively. The methods were precise and accurate. Excipients and degradation products did not interfere in the methods in studies of specificity. None of the factors studied in the analysis of robustness had a significant effect on the quantification of the ALG by the Pareto chart. The results of the assay obtained with LC CAD and LC UV were similar. The methods could be considered interchangeable and stability indicating, and can be applied as an appropriate QC tool for analysis of ALG in tablets.
引用
收藏
页码:400 / 405
页数:6
相关论文
共 50 条
  • [31] Development and validation of a stability-indicating LC-UV method for the determination of pantethine and its degradation product based on a forced degradation study
    Canavesi, Rossana
    Aprile, Silvio
    Varese, Elena
    Grosa, Giorgio
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2014, 97 : 141 - 150
  • [32] Development of a Validated Stability-Indicating LC Assay and Stress Degradation Studies of Linezolid in Tablets
    Cristiani C. G. O. Lopes
    Hérida R. N. Salgado
    Chromatographia, 2009, 69 : 129 - 135
  • [33] Development of a Validated Stability-Indicating LC Assay and Stress Degradation Studies of Linezolid in Tablets
    Lopes, Cristiani C. G. O.
    Salgado, Herida R. N.
    CHROMATOGRAPHIA, 2009, 69 : 129 - 135
  • [34] Validation of a stability-indicating LC method for assay of ezetimibe in tablets and for determination of content uniformity
    Doshi, Ashish S.
    Kachhadia, Pankaj K.
    Joshi, Hemendra S.
    CHROMATOGRAPHIA, 2008, 67 (1-2) : 137 - 142
  • [35] Validation of a Stability-Indicating LC Method for Assay of Ezetimibe in Tablets and for Determination of Content Uniformity
    Ashish S. Doshi
    Pankaj K. Kachhadia
    Hitendra S. Joshi
    Chromatographia, 2008, 67 : 499 - 499
  • [36] Validation of a Stability-Indicating LC Method for Assay of Ezetimibe in Tablets and for Determination of Content Uniformity
    Ashish S. Doshi
    Pankaj K. Kachhadia
    Hemendra S. Joshi
    Chromatographia, 2008, 67 : 137 - 142
  • [37] LC-UV and LC-MS methods for the determination of domoic acid
    Hess, P
    Morris, S
    Stobo, LA
    Brown, NA
    McEvoy, JDG
    Kennedy, G
    Young, PB
    Slattery, D
    McGovern, E
    McMahon, T
    Gallacher, S
    TRAC-TRENDS IN ANALYTICAL CHEMISTRY, 2005, 24 (04) : 358 - 367
  • [38] Determination of chemical stability of sitagliptin by LC-UV, LC-MS and FT-IR methods
    Gumieniczek, Anna
    Berecka, Anna
    Mroczek, Tomasz
    Wojtanowski, Krzysztof
    Dabrowska, Kinga
    Stepien, Katarzyna
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2019, 164 : 789 - 807
  • [39] APPLICATION OF PHOTODIODE ARRAY UV DETECTION IN THE DEVELOPMENT OF STABILITY-INDICATING LC METHODS - DETERMINATION OF MEFENAMIC-ACID
    MARON, N
    WRIGHT, G
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1990, 8 (01) : 101 - 105
  • [40] Validation of a stability indicating LC-UV method for [(N-morpholine)methylene] daunorubicin hydrochloride
    Jelinska, Anna
    Zajac, Marianna
    Cielecka-Piontek, Judyta
    Glab, Kinga
    Tomaszewicz, Bartosz
    Krause, Anna
    Oszczapowicz, Irena
    Wasowska, Malgorzata
    CHROMATOGRAPHIA, 2008, 67 (Suppl 1) : S107 - S111