Development and Validation of a Stability-indicating Method for Ibrutinib: Identification and Separation of Degradation Products, Known and Genotoxic Impurities Using RP-HPLC/PDA and QDa Mass Detectors

References

• https://www.drugbank.ca/drugs/DB09053, Accessed, August-22, (2019).
   Google Scholar
• https://www.pubchem.ncbi.nlm.nih.gov/compound/Ibrutinib, Accessed, August-22, (2019).
   Google Scholar
• https://en.wikipedia.org/wiki/Ibrutinib, Accessed, August-22, (2019).
   Google Scholar
• WIPO| PCT. (2016). W0 2016/164404 A1, Accessed, August-22, (2019).
   Google Scholar
• Information about the commercial from webpage: https://www.tga.gov.au/sites/default/files/auspar-Ibrutinib-160202-pi.pdf, Accessed, August-22, (2019)
   Google Scholar
• Lisa, A.R, (2017). Imbruvica (Ibrutinib) now FDA approved as fist-line treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma. Am. Health Drug Benefits. 10: 57-59.
   Google Scholar
• Vykuntam, U., Divya, N., Charishma, E., Harshavardan, K. and Shyamamla, M. (2016). Validated stability-indicating RP-HPLC method for determination of Ibrutinib. Indo American Journal of Pharmaceutical Science. 3(4): 324-330.
   Web of Science ®Google Scholar
• Vykuntam, U., Ayesha, T., Lavanya, K., Neeraja, V. and Sharma, V.C.J. (2016). Method development and validation of Ibrutinib by RP-HPLC in bulk and pharmaceutical dosage form. World Journal of Pharmacy and Pharmaceutical Sciences. 5(5): 868-874.
   Google Scholar
• Li-min, W., Zhen-xing X., Peng-fei L., Yong-le X., Xiang-xiang, W. and Min Z. (2016). A simple HPLC method for the determination of Ibrutinib in rabbit plasma and its application to a pharmacokinetic study. Latin American Journal of Pharmacy. 35(1): 130-34.
   Web of Science ®Google Scholar
• Suresh Babu, K., Ramu, G. and Rambabu, C. (2016). Validation of stability indicating rp-hplc method for the assay of Ibrutinib in pharmaceutical dosage form. Analytical Chemistry: An Indian Journal. 16(1): 007-019.
   Google Scholar
• De Vries, R., Huang, M., Bode, N., Jeiurkar, P., Jonq, J. D., Sukbunthermq, J., Sips, L., Weng, N., Timmerman, P. and Verhaeghe, T. (2015). Bio analysis of Ibrutinib and its active metabolite in human plasma: selectivity issue, impact assessment and resolution. Bioanalysis-Future Science. 7(20): 2713-24. doi: 10.4155/bio.15.159
   PubMed Web of Science ®Google Scholar
• Marwa, F., Helvenstein, M, and Bertrand, B. (2015). Ultra high performance liquid chromatography method for the determination of two recently FDA approved TKIs in human plasma using diode array detection. Journal of Analytical Methods in Chemistry. 6 pages.
   Web of Science ®Google Scholar
• Amit Gosar., Hussain Sayyed, and Tabrez Shaikh. (2018). Genotoxic impurities and its risk assessment in drug compound. Drug Designing & Intellectual Properties International Journal. 2(4): 227-232.
   Google Scholar
• Maria Rambla-Alegre. (2012). Evaluation of genotoxic impurities risk in pharmaceutical compounds. Bio chemistry & Pharmacology: Open Access, (10): Pages 1 & 2.
   Google Scholar
• ICH validation of analytical procedures: text and methodology Q2 (R1), Current step 4 version, incorporated (2005). www.ich.org/fileadmin/Public_Web_Site/ICH…/Q2_R1/…/Q2_R1_Guideline.pdf.
   Google Scholar
• ICH impurities in new drug products Q3B (R2), Current step 4 version, dated 2 (2006). www.ich.org/fileadmin/…/ICH_Products/…/Quality/Q3B_R2/…/Q3B_R2_Guideline.
   Google Scholar
• Trivikram, R. and Pandey, I.P. (2015). Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. Journal of Pharmaceutical Sciences and Research. 7(5): 238-241.
   Google Scholar
• Iram, F., Iram, H., Iqbal, A. and Husain, A. (2016). Forced degradation studies. Journal of Analytical & Pharmaceutical Research. 3(6): 00073.
   Google Scholar
• Blessy, M., Ruchi, D., Patel Prajesh, N., Prajapati, Y. and Agrawal, K. (2013). Development of forced degradation and stability indicating studies of drugs-A review. Journal of Pharmaceutical Analysis. 4(3): 159-165. doi: 10.1016/j.jpha.2013.09.003
   PubMedGoogle Scholar
• Murthy, M.V., Srinivas, K., Kumar, R. and Mukkanti. K. (2011). Development and validation of a stability-indicating LC method for determining Palonosetron hydrochloride, its related compounds and degradation products using naphthalethyl stationary phase. Journal of pharmaceutical and biomedical analysis. 56: 429-435. doi: 10.1016/j.jpba.2011.05.037
   PubMed Web of Science ®Google Scholar
• Lakshmi Narasimha Rao, K. and Padmaja Reddy, K. (2014). Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation. Journal of Saudi Chemical Society. 18: 593-600. doi: 10.1016/j.jscs.2012.01.006
   Web of Science ®Google Scholar
• Ashok, P.K., Thirupathi, D., Ravindra Kumar, Y. and Jayashree. A. (2017). Simultaneous Determination of Related Organic Impurities of Ibuprofen and Paracetamol in Combination Solid Dosage Form by Rp-Hplc With Qbd Approach. Oriental Journal of Chemistry. 33: 1461-1468. doi: 10.13005/ojc/330349
   Web of Science ®Google Scholar
• Murthy, M.V., Krishnaiah, C.H., Ramesh, K. and Mukkanti, K. (2013). Development of stability-indicating UPLC method for determining zolpidem tartrate and its product related variants in drug substance and drug products. Journal of Liquid Chromatography & Related Technologies. 36: 836-851. doi: 10.1080/10826076.2012.678027
   Web of Science ®Google Scholar
• Thirupathi, D., Ashok, K.P., Yashodharani, Y. and Naresh, K.K. (2019). A novel UPLC-PDA isocratic method for the quantification fulvestrant in oil-based pre-filled syringe injection matrix formulations. Journal of Analytical Science and Technology. 10: 12. doi: 10.1186/s40543-019-0171-7
   Web of Science ®Google Scholar
• Murthy, M.V., Krishnaiah, C., Srinivas, K., Rao, K.S., Kumar, NR. And Mukkanti, K. (2013). Development and validation of RP-UPLC method for the determination of darifenacin hydrobromide, its related compounds and its degradation products using design of experiments. Journal of Pharmaceutical and Biomedical Analysis. 72: 40-50. doi: 10.1016/j.jpba.2012.09.013
   PubMed Web of Science ®Google Scholar
• Thirupathi, D., Naresh, N.K., Ashok, K.P. and Sreekantha, B.J. (2019). Development and validation of a generic RP HPLC PDA method for the simultaneous separation and quantification of active ingredients in cold and cough medicines. Biomedical Chromatography. e4641.
   Google Scholar