PMID- 27816632
OWN - NLM
STAT- MEDLINE
DCOM- 20170523
LR  - 20220408
IS  - 1879-0720 (Electronic)
IS  - 0928-0987 (Linking)
VI  - 97
DP  - 2017 Jan 15
TI  - HPLC method for simultaneous analysis of ticagrelor and its organic impurities 
      and identification of two major photodegradation products.
PG  - 22-29
LID - S0928-0987(16)30483-3 [pii]
LID - 10.1016/j.ejps.2016.11.004 [doi]
AB  - A simple, fast and sensitive analytical method by high-performance liquid 
      chromatography (HPLC) was developed and validated for the simultaneous 
      determination of ticagrelor and two synthesis impurities. The HPLC method was 
      established using an Agilent 1200 Series equipment coupled to photodiode array 
      detector (PDA) at 270nm with a Zorbax Plus C(8) column (150x4.6mm, 5.0mum), 
      injection volume of 20muL, and a constant temperature of 25 degrees C. The mobile phase 
      consisted of acetonitrile: ammonium acetate 50mM (57:43, v/v) and pH adjusted to 
      8.2 with ammonium hydroxide 6M, at a flow rate of 0.7mL/min. No interference 
      peaks from excipients and diluent system indicated the specificity of the method. 
      The calibration curves showed determination coefficients (r(2))>0.99, calculated 
      by linear regression. The limit of quantitation (LOQ) for impurities 1 and 2 were 
      2.0 and 0.2mug/mL, respectively. Intra and interday relative standard deviations 
      (RSDs) were <2% for ticagrelor and <6% for the impurities, proving the precision 
      of the method. Besides, two mayor degradation products formed when sample 
      solutions of ticagrelor were exposed to UVC radiation were elucidated and the 
      mechanisms involved in the photolytic degradation of ticagrelor were proposed.
CI  - Copyright (c) 2016 Elsevier B.V. All rights reserved.
FAU - Bueno, Livia Maronesi
AU  - Bueno LM
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil. Electronic 
      address: maronesi@yahoo.com.br.
FAU - Manoel, Joanna Wittckind
AU  - Manoel JW
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Giordani, Camila Ferrazza Alves
AU  - Giordani CF
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Mendez, Andreas Sebastian Loureiro
AU  - Mendez AS
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Volpato, Nadia Maria
AU  - Volpato NM
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Schapoval, Elfrides Eva Scherman
AU  - Schapoval EE
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Steppe, Martin
AU  - Steppe M
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
FAU - Garcia, Cassia Virginia
AU  - Garcia CV
AD  - Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal do Rio 
      Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre, RS, Brazil.
LA  - eng
PT  - Journal Article
DEP - 20161103
PL  - Netherlands
TA  - Eur J Pharm Sci
JT  - European journal of pharmaceutical sciences : official journal of the European 
      Federation for Pharmaceutical Sciences
JID - 9317982
RN  - GLH0314RVC (Ticagrelor)
RN  - K72T3FS567 (Adenosine)
SB  - IM
MH  - Adenosine/*analogs & derivatives/analysis/chemistry
MH  - Chemistry Techniques, Analytical/*methods/standards
MH  - Chromatography, High Pressure Liquid/methods/standards
MH  - *Drug Contamination
MH  - *Photolysis
MH  - Ticagrelor
OTO - NOTNLM
OT  - Degradation products
OT  - Drug impurities
OT  - HPLC
OT  - Ticagrelor
OT  - Validation
EDAT- 2016/11/07 06:00
MHDA- 2017/05/24 06:00
CRDT- 2016/11/07 06:00
PHST- 2016/09/05 00:00 [received]
PHST- 2016/10/11 00:00 [revised]
PHST- 2016/11/01 00:00 [accepted]
PHST- 2016/11/07 06:00 [pubmed]
PHST- 2017/05/24 06:00 [medline]
PHST- 2016/11/07 06:00 [entrez]
AID - S0928-0987(16)30483-3 [pii]
AID - 10.1016/j.ejps.2016.11.004 [doi]
PST - ppublish
SO  - Eur J Pharm Sci. 2017 Jan 15;97:22-29. doi: 10.1016/j.ejps.2016.11.004. Epub 2016 
      Nov 3.