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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 8
First page : ( 3718) Last page : ( 3726)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00682.0

Separation, Identification and Quantification of process related Impurities and Stress Degradants of Olaparib by LC-ESI-Q-TOF-MS

Kallepalli Pramadvara*, Annapurna Mukthinuthalapati Mathrusri

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University, Visakhapatnam-530045, India

*Corresponding Author E-mail: pramadvarakallepalli4@gmail.com

Online published on 31 October, 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.

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Keywords

Olaparib, RP-HPLC, ESI-QTOF-MS, stability indicating, Impurities, validation, ICH guidelines.

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