STABILITY INDICATING VALIDATED HPLC METHOD FOR THE DETERMINATION OF ZANUBRUTINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM

  • M. VIJAYA KUMARI Department of Pharmaceutical Analysis, Brilliant Group of Technical Institutions, Abdullapurmet, Rangareddy (Dt.), Hyderabad, Telangana, India.
  • CH. BALASEKHAR REDDY Department of Pharmaceutical Analysis, Vagdevi College of Pharmacy, Gurazala, Andhra Pradesh, India.

Abstract

Objective: An accurate, rapid economical and straight forward, reliable assay technique was evolved and showed for the evaluation of zanubrutinib using reversed-phase high-performance liquid chromatography.


Methods: In the proposed method, efficient chromatographic separation was achieved applying acetonitrile and 0.1% orthophosphoric acid (50:50 v/v) as a mobile phase with a flow of 1 ml/min and the wavelength was observed at 220 nm. Chromatography was administered isocratically at ambient temperature and run time was approximately 6 min and the retention time (Rt) was observed as 4.358 min.


Results: The method was justified as per ICH guidelines. System suitability parameters were studied by injecting the quality six fold and results were well under acceptance criteria. Linearity study was administered between 10% and 150% levels, regression coefficient value was observed as 0.999. Limit of detection and limit of quantification were observed as 0.02 μg/ml and 0.2 μg/ml, respectively. Precision was found to be 0.74 for repeatability and 0.68 for intermediate precision. Recovery of the drug was found to be 98–102%, indicates that the recovery is in the acceptable limit. Validation results were found to be satisfactory and the method applicable for bulk and formulation analysis. Hence, it was evident that the proposed method was said to be suitable for regular analysis and quality control of pharmaceutical preparations.


Conclusion: The validation results were in good agreement with the acceptable limit. Relative standard deviation values which are <2.0% indicating the accuracy and precision of this method. Assay of retail formulation was administered and found to be 100.24% was present using the above method. Stress conditions of degradation in acidic, alkaline, peroxide, and thermal were studied. This developed method showed reliable, precise, accurate results under optimized conditions.

Keywords: Zanubrutinib, Validation, High-performance liquid chromatography, Stress studies

References

1. Skarbnik AP, Goy AH. Mantle cell lymphoma. State of the art. Clin Adv Hematol Oncol 2015;13:44-55.
2. Ye H, Desai A, Zeng D. Front line treatment for older patients with mantle cell lymphoma. Oncologist 2018;23:1337-48.
3. Ye H, Desai A, Huang S. Paramount therapy for young and fit patients with mantle cell lymphoma. Strategies for front line therapy. J Exp Clin Cancer Res 2018;37:150.
4. Palsingh S, Dammeijer F, Hendriks RW. Role of Bruton’s tyrosine kinase in B cell and malignancies. Mol Cancer 2018;17:57.
5. Montalban X, Arnold DL, Weber MS. Placebo controlled trial of an oral BTK inhibitor in multiple sclerosis. N Engl J Med 2019;380:2406-17.
6. Matsushita M, Yamadori T, Kato S, Takemoto Y, Inazawa J, Baba Y, et al. Identification and characterization of a novel SH3-domain binding protein, sab, which preferentially associates with Bruton’s tyrosine kinase (BtK). Biochem Biophys Res Commun 1998;245:337-43.
7. Burzomato V, Beato M, Groot-Kormelink P, Colquhoun D, Sivilotti LG. Single channel behavior of heteromeric alpha 1 beta glycine receptors. An attempt to detect a conformational change before the channel opens. J Neurosci 2004;24:10924-40.
8. Lape R, Colquhoun D, Sivilotti L. On the nature of partial agonism in the nicotinic receptor super family. Nature 2008;454:722-8.
9. Hanne M, Hawken SJ. Metaphors for illness in contemporary media. Med Humanit 2007;33:93-9.
10. Mcwhinney IR. Health and disease problems of definition. CMAJ 1987;136:815.
11. Jhonson R. The concept of sickness behavior a brief chronological account of four key discoveries. Vet Immunol Immunopathol 2002;87:443-50.
12. Vaibhav D. A simple model to solve complex drug toxicity problem. Toxicol Res 2019;8:157-71.
13. Hong M, Lee T, Kang SY, Kim SJ, Kim W, Ko YH. Nasal type NK-T cell lymphomas are more frequently T rather than NK lineage based on T-cell receptor gene, RNA and protein studies, lineage does not predict clinical behavior. Mod Pathol 2016;29:430-43.
14. Bachanova V, Miller JS. NK cells in therapy of cancer. Crit Rev Oncog 2014;19:133-41.
15. Rao KP, Bhavani P, Mohan S. Stability indicating RP-HPLC method for the estimation of diethyl carbamazine citrate, guaiphenesin and chlorpheniramine maleate. Int J Appl Pharm 2018;10:124-35.
16. Shyamal, Swarupa A, Anitha P. Validated stability indicating RP-HPLC method for determination of asenapine. Indo Am J Pharm Sci 2018;5:4107-13.
17. Kalpana GL, Devalarao G, Raju MB, Kumar TP. Validated stability indicating high performance liquid chromatographic method for the quantification of asenapine. Int J Pham Pham Sci 2015;7:61-5.
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KUMARI, M. V., and C. B. REDDY. “STABILITY INDICATING VALIDATED HPLC METHOD FOR THE DETERMINATION OF ZANUBRUTINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 10, Aug. 2020, pp. 159-62, doi:10.22159/ajpcr.2020.v13i10.38621.
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