Author(s): Pramadvara Kallepalli, Mukthinuthalapati Mathrusri Annapurna

Email(s): pramadvarakallepalli4@gmail.com

DOI: 10.5958/0974-360X.2018.00682.0   

Address: Pramadvara Kallepalli*, Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy,
GITAM (Deemed to be University, Visakhapatnam-530045, India
*Corresponding Author

Published In:   Volume - 11,      Issue - 8,     Year - 2018


ABSTRACT:
Olaparib (FDA approved) isa poly ADP ribose polymerase enzyme inhibitor used for the treatment of cancer. A new stability indicating LC-MS method was developed along with separation and identification of six process related impurities. Gradient mode was selected for the separation of Olaparib and its impurities using WATERS 2695 Series HPLC system having BDS Hypersil C8 column (250 mm x 4.6 mm, 5µm particle) was used (Total run time 60 min)with EMPOWER software (Quaternary pumps with WATERS 2996 PDA detector). Mass spectral study of these six impurities was performed on ESI- QTOF- MS system (Waters Quattro premier XE triple quadrupole connected with Acquity HPLC system) with Masslynx software. Forced degradation studies were conducted andthe degradants were analyzed with the help of massspectroscopy and three degradant products were found and are analyzed with the help of mass spectral studies. Olaparib was found to be sensitive towards oxidation and acidic hydrolysis. The proposed method is specific and selective.


Cite this article:
Pramadvara Kallepalli, Mukthinuthalapati Mathrusri Annapurna. Separation, Identification and Quantification of process related Impurities and Stress Degradants of Olaparib by LC-ESI-Q-TOF-MS. Research J. Pharm. and Tech 2018; 11(8): 3718-3726. doi: 10.5958/0974-360X.2018.00682.0

Cite(Electronic):
Pramadvara Kallepalli, Mukthinuthalapati Mathrusri Annapurna. Separation, Identification and Quantification of process related Impurities and Stress Degradants of Olaparib by LC-ESI-Q-TOF-MS. Research J. Pharm. and Tech 2018; 11(8): 3718-3726. doi: 10.5958/0974-360X.2018.00682.0   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2018-11-8-87


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RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

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