Available online at www.sciencedirect.com ScienceDirect Materials Today: Proceedings 14 (2019) 492–503 www.materialstoday.com/proceedings *Corresponding author e-mail:arthanareeswari@gmail.com 2214-7853 © 2019 Elsevier Ltd. All rights reserved. Selection and/or Peer-review under responsibility of 2nd International Conference On Recent Advances In Material Chemistry. New Rapid Stability indicating RP-UPLC Method for the Determination of Olaparib, its Related Substances and Degradation Products in Bulk drug and Dosage Form DasameswaraRao Kavitapu a,c, , Arthanareeswari Maruthapillai a *, Devikala S a , Arockia Selvi J a , M.Tamilselvi b , Sudarshan Mahapatra c , Pradeep Kumar G c , Pradeep Kumar Tyagi c a Department of Chemistry, SRM Institute of Science and Technology, Kattankulathur-603 203, India b Department of Chemistry, Thiru Kolanjiappar Government Arts College, Virudhachalam-606001, India c PDO Dr.Reddy’s Laboratories Limited, Hyderabad-500090, India Abstract A rapid, specific, sensitive, and precise reverse-phase UPLC method was developed for the quantitative determination of a typical anticancer drug. Olaparib and its eight potential impurities in drug substances is described in this report. Statistical experimental designs (DOE) are used as advancement over conventional experimental approach .It provides more accurate results in fewer runs compared with conventional methods. Chromatographic separation was achieved on a Waters Acquity UPLC® BEH C18 (2.1 mm × 100 mm, 1.7 micron) column, using buffer (1.0ml Orthophosphoric acid in 1000ml water) and acetonitrile in gradient elution mode. The flow rate was kept at 0.4mL/min; thermostated at 35˚C with a short runtime of 15 min. The optimized method was found to produce symmetric and sharp peaks with good separation between processes related impurities and degradation impurities. Quantification is achieved with photodiode array detection at 220 nm over the concentration range of 10- 20 μg/mL. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating capability of the developed UPLC method. Developed method is validated as per ICH guidelines and found to be linear, accurate, specific, selective, precise and robust. The method is useful during process development and quality of bulk manufacturing. Keywords: Olaparib, OPD5A impurity (IMP-I), OPD3A impurity (IMP-II), Methyl ester impurity (IMP-III), Dimer impurity (IMP-IV), DiCPC impurity (IMP-V), OPD4A impurity (Impurity-VI) 1. Introduction: Olaparib (AZD-2281, trade name Lynparza) is an FDA-approved targeted therapy for cancer, developed by KuDOS Pharmaceuticals and later by Astra Zeneca. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase (PARP), an enzyme involved in DNA repair [1]. It acts against cancers in people with hereditary BRCA1 or BRCA2 mutations, which include some ovarian, breast, and prostate cancers [2]. In December 2014, Olaparib was approved for use as a single agent by the EMA and the FDA [3][4][5]. The FDA approval is in for germline BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy. BRCA1/2 mutations may be genetically predisposed to development of some forms of cancer, and may be resistant to other forms of cancer treatment. However, these cancers sometimes have a unique vulnerability, as the cancer cells have increased reliance on PARP to repair their DNA and enable them to continue