Vol. 6 (01) pp. 836-843 DOI: 10.21474/IJAR01/6290

A SENSITIVE BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RUCAPARIB IN HUMAN PLASMA BY LC-ESI-MS/MS.

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  • Institute of Pharmacy, C.S.J.M University, Kanpur, uttar pradesh, India.
  • NRI College of Pharmacy, pothavarappadu, Andhrapradesh, India.
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Abstract

A simple, sensitive and specific liquid chromatography?tandem mass spectrometry (LC-MS/MS) method was developed for the quantification of Rucaparib (RP) in human plasma using Rucaparib-d3 (RPD3) as an internal standard (IS). Chromatographic separation was performed on Xbridge C18, 50 x 4.6 mm, 5 m column with an isocratic mobile phase composed of 10mM Ammonium formate and Methanol in the ratio of (20:80 v/v), at a flow-rate of 0.7 mL/min. RP and RPD3 were detected with proton adducts at m/z 323.4  170.1 and 328.4 ? 170.1 in multiple reaction monitoring (MRM) positive mode respectively. Liquid-Liquid extraction method was used to extract the drug and IS. The method was validated over a linear concentration range of 5.0-5000.0 pg/mL with correlation coefficient (r2) ≥ 0.9994. This method demonstrated intra and inter-day Precision within 0.7 to 2.0 and 0.7 to 2.7 % and Accuracy within 101.4 to 102.4 and 99.5 to 104.8 %. Rucaparib (RP) was found to be stable throughout freeze-thawing cycles, bench top and postoperative stability studies.

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References

  1. US Food and Drug Administration. FDA grants accelerated approval to new treatment for advanced ovarian cancer. Press release. December 19, 2016.
  2. US Food and Drug Administration. FDA approves Lynparza to treat advanced ovarian cancer: first LDT companion diagnostic test also approved to identify appropriate patients. Press release. December 19, 2014. ww.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm.Accessed January 23, 2017.
  3. Nile DL, Rae C, Hyndman IJ, Gaze MN, Mairs RJ: An evaluation in vitro of PARP-1 inhibitors, rucaparib and olaparib, as radiosensitisers for the treatment of neuroblastoma. BMC Cancer. 2016 Aug 11;16:621.
  4. Jenner ZB, Sood AK, Coleman RL: Evaluation of rucaparib and companion diagnostics in the PARP inhibitor landscape for recurrent ovarian cancer therapy. Future Oncol. 2016 Jun;12(12):1439-56.
  5. Drew Y, Ledermann J, Hall G, Rea D, Glasspool R, Highley M, Jayson G, Sludden J, Murray J, Jamieson D, Halford S, Acton G, Backholer Z, Mangano R, Boddy A, Curtin N, Plummer R: Phase 2 multicentre trial investigating intermittent and continuous dosing schedules of the poly(ADP-ribose) polymerase inhibitor rucaparib in germline BRCA mutation carriers with advanced ovarian and breast cancer. Br J Cancer. 2016 Mar 29;114(7):723-30.
  6. Dockery LE, Gunderson CC, Moore KN: Rucaparib: the past, present, and future of a newly approved PARP inhibitor for ovarian cancer. Onco Targets Ther. 2017 Jun 19;10:3029-3037.
  7. Emmy M.Dolman, Ilona J.M.den, Hartog Jan, J.Molenaar Jan, H.M.Schellens, Jos H.Beijnen, Rolf W.Sparidans. Liquid chromatography?tandem mass spectrometric assay for the cyclin-dependent kinase inhibitor AT7519 in mouse plasma. Journal of Pharmaceutical and Biomedical Analysis, 88,?2014, 216-220.
  8. National Cancer Institute. Ovarian epithelial, fallopian tube, and primary peritoneal cancer treatment (PDQ)?health professional version. Updated January 2017. www.cancer.gov/types/ovarian/hp/ovarian-epithelial-treatment-pdq. Accessed January 19, 2017.
  9. Swisher EM, Lin KK, Oza AM, et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial.?Lancet Oncol. 2017;18:75-87.
  10. Pal T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases.?Cancer. 2005;104:2807-2816.
  11. Rolf W.Sparidansa, Selvi Durmusb, Alfred H.Schinkelb, Jan H.M.Schellensac, Jos H.Beijnenac. Liquid chromatography?tandem mass spectrometric assay for the PARP inhibitor Rucaparib in plasma. Journal of Pharmaceutical and Biomedical Analysis. 88,?2014, 626-629.
  12. Guidance for industry: bioanalytical method validation, U.S. Department of health and human services, food and drug administration, center for drug evaluation and research (CDER), Center for biologics evaluation and research (CBER), May 2001.

How to Cite This Article

Vamseekrishna Gorijavolu, Ajay Kumar Gupta and Y. A. Chowdary. (2018); A SENSITIVE BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RUCAPARIB IN HUMAN PLASMA BY LC-ESI-MS/MS., Int. J. of Adv. Res., 6 (01), 836-843, ISSN 2320-5407. DOI: https://doi.org/10.21474/IJAR01/6290

Corresponding Author

Vamseekrishna Gorijavolu
Institute of Pharmacy, C.S.J.M University, Kanpur,uttar pradesh , India
Creative Commons Attribution 4.0 This work is licensed under a Creative Commons Attribution 4.0 International License.