NOVEL RP-HPLC METHOD FOR THE QUANTIFICATION OF ABIRATERONE ACETATE
Abstract
Simple, rapid, accurate and specific RP-HPLC method has been developed for quantitative estimation of
Abiraterone acetate in bulk and tablet. Separation was attained by using Acclaim C18 column (50mm x
4.6 mm, 5) at 25C and 80:20 v/v acetonitrile:ammonium acetate buffer(10mM) of pH 6.0 with flow rate
of 1ml/min as mobile phase and the drug was detected at 254 nm. Analytical method was said to be
linear over a range of 0.125-60 g/ml with correlation constant of 0.999. Method was appeared to be
precise, robust and rugged. LOD and LOQ were found to be 10 ng/ml and 50 ng/ml respectively and the
mean recovery value as 100.52%.Stability indicating capability of this method has been demonstrated by
analyzing stressed samples of drug and found labile to acidic, alkaline, oxidative, thermal and photolytic
conditions. Above method was applied for the estimation in API, formulation and dissolution testing of
the dosage form. Percentage assay of the formulation was found to be 101.66%w/w. Drug released to an
extent of 85.29% at 30 minutes as per FDA published method. Thus, the analytical procedure is reliable
and offers advantage in terms of speed; so could be effectively used for the routine quality control
purpose.
Full Text:
PDFReferences
Food and Drug Administration Approves
Abiraterone for Treatment of Men with
Advanced Prostate Cancer. Available
from:
http://www.pcf.org/site/c.leJRIROrEpH/b.
/k.82CC/
Food_and_Drug_Administration_Approve
s_Abiraterone_for_Treatment_of_Men_wit
h_Advanced_Prostate_Cancer.htm
Abiraterone Acetate (CAS 154229-18-2).
Available from:
http://www.scbt.com/datasheet-207240-
abiraterone-acetate.html
Oxidation stability of abiraterone acetate
WO 2014009437 A1. Available from:
http://www.google.com/patents/WO201400
A1?cl=en
Zytiga. Available from:
http://www.globalrph.com/drug_abiratero
ne.htm
Chemistry Review (S). Available from:
http://www.accessdata.fda.gov/drugsatfda
_docs/nda/2011/202379Orig1s000ChemR.
Martins V, Asad Y, Wilsher N, Raynaud
F, A validated liquid chromatographic–
tandem mass spectroscopy method for the
quantification of abiraterone acetate and
abiraterone in human plasma. J
Chromatogr B Analyt Technol Biomed
Life Sci. 2006;843(2):262-267.
Gaurav S, Punde R, Farooqui J,
Zainuddin M, Rajagopal S, Mullangi R,
Development and validation of a highly
sensitive method for the determination of
abiraterone in rat and human plasma by
LC-MS/MS-ESI: application to a
pharmacokinetic study. Biomed
Chromatogr. 2012;26(2):761-8.
Kumar SV, Rudresha G, Gaurav S,
Zainuddin,Dewang P, Kethiri RR,
Rajagopal S, Mullangi R, Validated RPHPLC/
UV method for the quantitation of
abiraterone in rat plasma and its
application to a pharmacokinetic study in
rats. Biomed Chromatogr. 2013; 27(2):
-7.
Khdera A, Darwish I, Bamanea F,
Analysis of abiraterone stress degradation
behavior using liquid chromatography
coupled to ultraviolet detection and
electrospray ionization mass
spectrometry. J Pharm Biomed
Anal. 2013; 23:74-77.
Gong A, Zhu X, β-cyclodextrin Sensitized
Spectrofluorimetry for the Determination
of Abiraterone Acetate and
Abiraterone. J.
Fluoresc. 2013;23(6):1279-86.
International Conference on
Harmonization, Note for guidance on
stability testing of new drug substance
and products [ICH, Q1A (R2)]. In:
International conference on
harmonization of technical requirement
for registration of pharmaceutical for
human use, Geneva (2003).
International Conference on
Harmonization, Note for guidance on
Impurities in New Drug Products [ICH,
Q3B (R2)]. In: International conference
on harmonization of technical
requirement for registration of
pharmaceutical for human use, Geneva
(2006).
International Conference on
Harmonization, Note for guidance on
Validation of Analytical Procedures: Test
and Methodology [ICH, Q2 (R1)]. In:
International conference on
harmonization of technical requirement
for registration of pharmaceutical for
human use, Geneva, 2005. Available
form:http://www.ich.org/fileadmin/Public
_Web_Site/ICH_Products/Guidelines/Qua
lity/Q2_R1/Step4/Q2_R1__Guideline.pdf
Office of Generic Drugs,
FDA. Dissolution method for abiraterone
acetate. Available
from:http://www.accessdata.fda.gov/scrip
ts/cder/dissolution/dsp_SearchResults_Di
ssolutions.cfm
USP Pending Monograph-Abiraterone
acetate. Available from:
http://www.usp.org/sites/default/files/usp
_pdf/EN/USPNF/m7730.pdf
Refbacks
- There are currently no refbacks.
