A sensitive liquid chromatography tandem mass spectrometric method development and validation for ribociclib and its formulation

J. Ramesh; B. Babu; R. Sangamithra; D. Anandha Jothi; S.N. Meyyanathan; B. Gowramma

doi:10.7324/JAPS.2024.178562

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Abstract

This study implies to development of a sensitive liquid chromatography tandem mass spectrometry method. Further using this method ribociclib can be estimated in the drug formulation. Ribociclib was recently approved by the United States Food and Drug Administration in the year 2017 for metastatic and advanced breast cancer, which is used for resistant patients to endocrine therapy and it targets cyclin-dependent kinase 4 and 6 inhibitors. The stationary phase was Phenomenex C₁₈(50 × 4.6 mm, 3 microns), with a mobile phase combination of acetonitrile and 10 mM ammonium acetate (90:10 v/v ratio) with a flow of 0.7 ml/minutes. Ribociclib was detected using liquid chromatography-tandem mass spectrometry in positive transition at m/z 435.0. The linearity ranges between 5 and 100 ng/ml. The Ribociclib correlation coefficient (R2) was linear, with an R2 value of 0.9991. The drug had a retention time (RT) of 1.022 minutes, and a total run time of 3 minutes. According to the literature survey, there is a limited isocratic method for the selected drug hence, we developed an isocratic which is a quick, accurate, and efficient method for determining ribociclib and its formulation.

Keyword: Ribociclib cyclin-dependent kinase blocker liquid chromatography tandem mass spectrometry method validation formulation

Citation:

Ramesh J, Babu B, Sangamithra R, Anandha Jothi D, Meyyanathan SN, Gowramma B. A sensitive liquid chromatography tandem mass spectrometric method development and validation for ribociclib and its formulation. J Appl Pharm Sci. 2024. Online First. http://doi.org/10.7324/JAPS.2024.178562

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Reference

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4. Turkovi? L, Bo?kor L, Ekpenyong O, Silovski T, Lovri? M, Crnkovi? S, et al. Development and validation of a novel LC-MS/MS method for the simultaneous determination of abemaciclib, palbociclib, ribociclib, anastrozole, letrozole, and fulvestrant in plasma samples: a prerequisite for personalized breast cancer treatment. Pharmaceuticals. 2022;15(5):614. https://doi.org/10.3390/ph15050614
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7. Martínez-Chávez A, Rosing H, Hillebrand M, Tibben M, Schinkel AH, Beijnen JH. Development and validation of a bioanalytical method for the quantification of the CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse matrices using liquid chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 2019;411:5331-45. https://doi.org/10.1007/s00216-019-01932-w
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9. Sahu AK, Jadav T, Rajput N, Sharma MK, Sengupta P. Bioanalysis by LC-MS/MS and preclinical pharmacokinetic interaction study of ribociclib and oleanolic acid. Bioanalysis. 2022;14(15):1051-65. https://doi.org/10.4155/bio-2022-0123
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11. Kala A, Patel YT, Davis A, Stewart CF. Development and validation of LC-MS/MS methods for the measurement of ribociclib, a CDK4/6 inhibitor, in mouse plasma and Ringer’s solution and its application to a cerebral microdialysis study. J. Chromatogr. B. 2017;1057:110-7. https://doi.org/10.1016/j.jchromb.2017.05.002
12. Sahu AK, Goswami A, Kate AS, Sengupta P. Identification and structural characterization of potential degraded impurities of ribociclib by time of flight-tandem mass spectrometry, and their toxicity prediction. J. Pharm. Biomed. Anal. 2021;197:113933. https://doi.org/10.1016/j.jpba.2021.113933
13. Harron DW. Technical requirements for registration of pharmaceuticals for human use: the ICH process. Textb Pharm Med. 2013;18:447-60. https://doi.org/10.1002/9781118532331.ch23

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Ramesh J [PubMed] [Google Scholar ]

Babu B [PubMed] [Google Scholar ]

Sangamithra R [PubMed] [Google Scholar ]

Jothi D A [PubMed] [Google Scholar ]

Meyyanathan S [PubMed] [Google Scholar ]

B G [PubMed] [Google Scholar ]

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1. Wolff AC, Hammond ME, Allison KH, Harvey BE, McShane LM, Dowsett M. HER2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline focused update summary. J Oncol Pract. 2018;14(7):437-41. https://doi.org/10.1200/JOP.18.00206

2. Burke SM, Kamal M, Goey AK. Development and validation of a quantitative LC-MS/MS method for CDK4/6 inhibitors palbociclib, ribociclib, abemaciclib, and abemaciclib-m2 in human plasma. Ther Drug Monit. 2023;45(3):327-36. https://doi.org/10.1097/FTD.0000000000001063

3. Posocco B, Buzzo M, Poetto AS, Orleni M, Gagno S, Zanchetta M, et al. Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application. PLoS One. 2020;15(2):e0228822. https://doi.org/10.1371/journal.pone.0228822

4. Turkovi? L, Bo?kor L, Ekpenyong O, Silovski T, Lovri? M, Crnkovi? S, et al. Development and validation of a novel LC-MS/MS method for the simultaneous determination of abemaciclib, palbociclib, ribociclib, anastrozole, letrozole, and fulvestrant in plasma samples: a prerequisite for personalized breast cancer treatment. Pharmaceuticals. 2022;15(5):614. https://doi.org/10.3390/ph15050614

5. Drug Information. [Online]. Available from: http://www.drugs.com (Accessed 10 July 2023).

6. Braal CL, Lam MH, Rienks T, van Tilborg CJ, Heuts W, Heijns JB, et al. Quantification of ribociclib in dried blood spots by LC-MS/MS: method development and clinical validation. J. Pharm. Biomed. Anal. 2021;201:114118. https://doi.org/10.1016/j.jpba.2021.114118

7. Martínez-Chávez A, Rosing H, Hillebrand M, Tibben M, Schinkel AH, Beijnen JH. Development and validation of a bioanalytical method for the quantification of the CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse matrices using liquid chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 2019;411:5331-45. https://doi.org/10.1007/s00216-019-01932-w

8. Mlinari? Z, Turkovi? L, Begovi? I, Nigovi? B, Serti? M. Rapid capillary electrophoresis method for simultaneous determination of abemaciclib, ribociclib, and palbociclib in pharmaceutical dosage forms: a green approach. Mol. 2022;27(21):7603. https://doi.org/10.3390/molecules27217603

9. Sahu AK, Jadav T, Rajput N, Sharma MK, Sengupta P. Bioanalysis by LC-MS/MS and preclinical pharmacokinetic interaction study of ribociclib and oleanolic acid. Bioanalysis. 2022;14(15):1051-65. https://doi.org/10.4155/bio-2022-0123

10. Bao X, Wu J, Sanai N, Li J. Determination of total and unbound ribociclib in human plasma and brain tumor tissues using liquid chromatography coupled with tandem mass spectrometry. J. Pharm. Biomed. Anal. 2019;166:197-204. https://doi.org/10.1016/j.jpba.2019.01.017

11. Kala A, Patel YT, Davis A, Stewart CF. Development and validation of LC-MS/MS methods for the measurement of ribociclib, a CDK4/6 inhibitor, in mouse plasma and Ringer’s solution and its application to a cerebral microdialysis study. J. Chromatogr. B. 2017;1057:110-7. https://doi.org/10.1016/j.jchromb.2017.05.002

12. Sahu AK, Goswami A, Kate AS, Sengupta P. Identification and structural characterization of potential degraded impurities of ribociclib by time of flight-tandem mass spectrometry, and their toxicity prediction. J. Pharm. Biomed. Anal. 2021;197:113933. https://doi.org/10.1016/j.jpba.2021.113933

13. Harron DW. Technical requirements for registration of pharmaceuticals for human use: the ICH process. Textb Pharm Med. 2013;18:447-60. https://doi.org/10.1002/9781118532331.ch23