PMID- 23158354
OWN - NLM
STAT- MEDLINE
DCOM- 20130501
LR  - 20191210
IS  - 1873-3573 (Electronic)
IS  - 0039-9140 (Linking)
VI  - 101
DP  - 2012 Nov 15
TI  - Development and validation of a simple and sensitive high performance liquid 
      chromatographic method for the simultaneous determination of anastrozole, 
      bicalutamide, tamoxifen, and their synthetic impurities.
PG  - 495-503
LID - S0039-9140(12)00824-7 [pii]
LID - 10.1016/j.talanta.2012.10.004 [doi]
AB  - A simple and sensitive analytical method for simultaneous determination of 
      anastrozole, bicalutamide, and tamoxifen as well as their synthetic impurities, 
      anastrozole pentamethyl, bicalutamide 3-fluoro-isomer, and tamoxifen e-isomer, 
      was developed and validated by using high performance liquid chromatography 
      (HPLC). The separation was achieved on a Symmetry((R)) C-8 column (100x4.6 mm i.d., 
      3.5 mum) at room temperature (+/-24  degrees C), with a mobile phase consisting of 
      acetonitrile/water containing 0.18% N,N dimethyloctylamine and pH adjusted to 3.0 
      with orthophosphoric acid (46.5/53.5, v/v) at a flow rate of 1.0 mL min(-1) 
      within 20 min. The detection was made at a wavelength of 270 nm by using 
      ultraviolet (UV) detector. No interference peaks from excipients and relative 
      retention time indicated the specificity of the method. The calibration curve 
      showed correlation coefficients (r) >0.99 calculated by linear regression and 
      analysis of variance (ANOVA). The limit of detection (LOD) and limit of 
      quantitation (LOQ), respectively, were 2.2 and 6.7 mug mL(-1) for anastrozole, 
      2.61 and 8.72 mug mL(-1) for bicalutamide, 2.0 and 6.7 mug mL(-1) for tamoxifen, 
      0.06 and 0.22 mug mL(-1) for anastrozole pentamethyl, 0.02 and 0.07 mug mL(-1) for 
      bicalutamide 3-fluoro-isomer, and 0.002 and 0.007 mug mL(-1) for tamoxifen 
      e-isomer. Intraday and interday relative standard deviations (RSDs) were <2.0% 
      (drugs) and <10% (degradation products) as well as the comparison between two 
      different analysts, which were calculated by f test.
CI  - Copyright (c) 2012 Elsevier B.V. All rights reserved.
FAU - Gomes, Fabio Pereira
AU  - Gomes FP
AD  - School of Pharmacy, Pharmacy Australia Centre of Excellence, The University of 
      Queensland, 20 Cornwall Street, Woolloongabba, QLD 4102, Australia. 
      f.pereiragomes@uq.edu.au
FAU - Garcia, Pedro Lopez
AU  - Garcia PL
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20121016
PL  - Netherlands
TA  - Talanta
JT  - Talanta
JID - 2984816R
RN  - 0 (Anilides)
RN  - 0 (Nitriles)
RN  - 0 (Tosyl Compounds)
RN  - 0 (Triazoles)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - 2Z07MYW1AZ (Anastrozole)
RN  - A0Z3NAU9DP (bicalutamide)
SB  - IM
MH  - Analysis of Variance
MH  - Anastrozole
MH  - Anilides/*analysis
MH  - Calibration
MH  - Chromatography, High Pressure Liquid/*methods
MH  - Limit of Detection
MH  - Nitriles/*analysis
MH  - Reproducibility of Results
MH  - Tamoxifen/*analysis
MH  - Tosyl Compounds/*analysis
MH  - Triazoles/*analysis
EDAT- 2012/11/20 06:00
MHDA- 2013/05/02 06:00
CRDT- 2012/11/20 06:00
PHST- 2012/08/10 00:00 [received]
PHST- 2012/10/02 00:00 [revised]
PHST- 2012/10/04 00:00 [accepted]
PHST- 2012/11/20 06:00 [entrez]
PHST- 2012/11/20 06:00 [pubmed]
PHST- 2013/05/02 06:00 [medline]
AID - S0039-9140(12)00824-7 [pii]
AID - 10.1016/j.talanta.2012.10.004 [doi]
PST - ppublish
SO  - Talanta. 2012 Nov 15;101:495-503. doi: 10.1016/j.talanta.2012.10.004. Epub 2012 
      Oct 16.