OPEN-ACCESS PEER-REVIEWED
1Ravikumar Vejendla, 2Sri Hari Galla, 3Sivanna Chithanna
1Department of Pharmaceutical Analysis, St.Mary’s Pharmacy College, Deshmukhi, Hyderabad.
2Medicinal Chemistry Department, University of Louisville, 505 South Hancock Street, Louisville, KY 40202, USA
3Medicinal Chemistry Department, University of Louisville, 505 South Hancock Street, Louisville, KY 40202, USA
Abstract
Background: authors want to define the procedure for LC-ESI-MS/MS, a technique utilized in bio-analytical research to establish a simple technique for determining the level of Niraparib in K3EDTA plasma from human beings, is a combination of liquid chromatography, electro spray ionization and mass spectro-photometry. Niraparib in plasma samples has been measured using a sensitive and efficient technique.
Materials and methods: Chromatographic elution was done by using 10mM Ammonium acetate pH-5.0 (A) : acetonitrile (B) in the ratio of 10:90v/v as mobile phase having flow rate of 1.0 milli-liter per minute, Gemini 5µ C18150 x 4.6 mm column. 70% division of flow was used for chromatographic separation of Niraparib with an ISTD as Niraparib-D5.
Results: System Suitability: Area ratio < 2.06%, ISTD RT, and analyte RT% CV ≤ 2.06%. System performance: internal standard residual ≤ 1.07, analyte carryover < 6045, signal to noise ratio ≥ 270.0. Over LOQ & LOQQC 0.0005 µg/ml, LQC 0.00134 µg/mL, MQC 0.02 µg/mL and HQC 0.04 µg/mL, this approach is verified, ULOQ 0.05 µg/mL, and linear concentration range of 0.0005 µg/mL to 0.05 µg/mL with a correlation coefficient (r2) of ≥ 0.9997. Stability investigations indicated that the developed conduct was suitable for use with K3EDTA plasma samples when it was validated.
Summary: The LC-MS/MS technique that was created to quantify the amount of Niraparib in the biological matrix worked well for routine blood sample analysis from patients for pharmacokinetics research and medication monitoring.
Keywords: Niraparib, Niraparib-D5, LC-ESI-MS/MS, LQC, MQC, HQC, ULOQ, Validation, Stability
References
[1]. Chao SY, Chiang JH, Huang AM, Chang WS. An integrative approach to identifying cancer chemoresistance-associated pathways. BMC medical genomics. 2011 Dec;4:1-4.
[2]. Raedler LA. Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
[3]. Heo YA, Duggan ST. Niraparib: a review in ovarian cancer. Targeted oncology. 2018 Aug;13:533-9.
[4]. AlHilli MM, Becker MA, Weroha SJ, Flatten KS, Hurley RM, Harrell MI, Oberg AL, Maurer MJ, Hawthorne KM, Hou X, Harrington SC. In vivo anti-tumor activity of the PARP inhibitor Niraparib in homologous recombination deficient and proficient ovarian carcinoma. Gynecologic oncology. 2016 Nov 1;143(2):379-88.
[5]. Del Campo JM, Mirza MR, Berek JS, Provencher DM, Emons G, Fabbro M, Lord R, Colombo N, Petru E, Wenham RM, Herrstedt J. The successful phase 3 Niraparib ENGOT-OV16/NOVA trial included a substantial number of patients with platinum resistant ovarian cancer (OC).
[6]. De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M. Cancer survival in Europe 1999–2007 by country and age: results of EUROCARE-5—a population-based study. The lancet oncology. 2014 Jan 1;15(1):23-34.
[7]. Risch HA, McLaughlin JR, Cole DE, Rosen B, Bradley L, Fan I, Tang J, Li S, Zhang S, Shaw PA, Narod SA. Population BRCA1 and BRCA2 mutation frequencies and cancer penetrances: a kin–cohort study in Ontario, Canada. Journal of the National Cancer Institute. 2006 Dec 6;98(23):1694-706.
[8]. Jackson SP, Bartek J. The DNA-damage response in human biology and disease. Nature. 2009 Oct 22;461(7267):1071-8.
[9]. Ashworth A. A synthetic lethal therapeutic approach: poly (ADP) ribose polymerase inhibitors for the treatment of cancers deficient in DNA double-strand break repair. Journal of Clinical Oncology. 2008 Aug 1;26(22):3785-90.
[10]. He B. Specific killing of BRCA2-deficient tumours with inhibitors of poly (ADP-ribose) polymerase. Nature. 2005;434:913-7.
[11]. Farmer H, McCabe N, Lord CJ, Tutt AN, Johnson DA, Richardson TB, Santarosa M, Dillon KJ, Hickson I, Knights C, Martin NM. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature. 2005 Apr 14;434(7035):917-21.
[12]. Lord CJ, Ashworth A. The DNA damage response and cancer therapy. Nature. 2012 Jan 19;481(7381):287-94.
[13]. Van Andel L. Zhang Z,Lu S, Kansra V, et al. Liquid chromatography-tandem mass spectrometry assay for the quantification of Niraparib and its metabolite M1 in human plasma and urine. J Chromatogram B Analyst Techno Biomed life Sci. 2017 Jan 1:1040:14-21.
[14]. Bruin MA, de Vries N, Lucas L, Rosing H, Huitema AD, Beijnen JH. Development and validation of an integrated LC-MS/MS assay for therapeutic drug monitoring of five PARP-inhibitors. Journal of Chromatography B. 2020 Feb 1;1138:121925.
[15]. Lau HS, Florax C, Porsius AJ, De Boer A. The completeness of medication histories in hospital medical records of patients admitted to general internal medicine wards. British journal of clinical pharmacology. 2000 Jun;49(6):597-603.
[16]. Xu RN, Fan L, Rieser MJ, El-Shourbagy TA. Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS. Journal of pharmaceutical and biomedical analysis. 2007 Jun 28;44(2):342-55.
[17]. Hill H. Development of bioanalysis: a short history.
[18]. Wilson ID. Bio-analytical separations. Elsevier; 2003 Sep 3.
[19]. Rozet E, Dewé W, Ziemons E, Bouklouze A, Boulanger B, Hubert P. Methodologies for the transfer of analytical methods: a review. Journal of Chromatography B. 2009 Aug 1;877(23):2214-23.
[20]. Wells DA. High throughput bio-analytical sample preparation-methods and automation strategies. Progress in Pharmaceutical and Biomedical Analysis, 2003. 2003.
[21]. Rogatsky E, Stein D. Evaluation of matrix effect and chromatography efficiency: new parameters for validation of method development. Journal of the American Society for Mass Spectrometry. 2005 Nov;16(11):1757-9.
[22]. Ünal DÖ, Güler S, Erol DD. Development and validation of bio-analytical method for determination of flurbiprofen from human plasma by liquid chromatography. Hacettepe University Journal of the Faculty of Pharmacy. 2009 Jan 1(1):25-35.
[23]. Hill HM. Bio-analytical methods validation: A critique of the proposed FDA guidance. Chromatographia. 2000 Jan;52:S65-9. (www.fda.gov)