STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RUXOLITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM USING UPLC

RAHEEN TABASSUM; S. H. RIZWAN

doi:10.22159/ijpps.2023v15i2.46839

Authors

RAHEEN TABASSUM Department of Pharmaceutical Analysis, Supervisor and Guide for the Project https://orcid.org/0000-0002-4208-8675
S. H. RIZWAN Department of Pharmaceutical Analysis, Supervisor and Guide for the Project https://orcid.org/0000-0002-4091-4419

DOI:

https://doi.org/10.22159/ijpps.2023v15i2.46839

Keywords:

Ruxolitinib, UPLC, Linearity, Chromatographic separation high resolution, Shorter retention, Stability studies

Abstract

Objective: To establish a simple and selective UPLC (Ultra-high Performance Liquid Chromatography) method for the determination of Ruxolitinib in tablet and bulk dosage forms.

Methods: Chromatographic separation was achieved on a C8 column with the dimensions of (250×4.6m ID) 5 µm length; the mobile phase composition was a mixture of pH 6.2 with glacial acetic acid: Methanol: acetonitrile in the ratio of 40:30:30 was passed through the designated column with a flow rate of 1 ml per minute and the UV (Ultra Violet) detection was witnessed at 254 nm.

Results: Linearity was observed in the range 50-150 µg/ml for Ruxolitinib (r² =0.9998) for drugs estimated by the proposed methods was in good agreement with the label claim. The % recovery of the drug was found to be between 98 and 102%. The drug was used for determining stability studies for acid, alkali, thermal, photolytic, and peroxide degradation.

Conclusion: The method for determining Ruxolitinib was discovered to be simple, precise, accurate, and high resolution, with a shorter retention time, making it more acceptable and cost-effective for routine analysis.

Downloads

Download data is not yet available.

References

Pardanani A, Tefferi A. Targeting myeloproliferative neoplasms with JAK inhibitors. Lippincott Williams & Wilkins; 2015. Mayo Clinic. Available from: https://mayoclinic.pure.elsevier.com/en/publications/targeting-myeloproliferative-neoplasms-with-jak-inhibitors. [Last accessed on 05 Dec 2022]

A CFM-T. Myelofibrosis: an update on current pharmacotherapy and Future Directions. United States National Library of Medicine. Expert Opinion on Pharmacotherapy. Available from: https://pubmed.ncbi.nlm.nih.gov/23514013. [Last accessed on 05 Dec 2022]

Alfonso RG, Ara HDM, Glen RH, Thomas M, Nicholas GP, Roger LS. Chromatography. In: Remington: the science and practice of pharmacy. 20th ed. Philadelphia: Lippincott Williams & Wilkins; 2000. p. 587.

Charlier B, Marino L, Dal Piaz F, Pingeon M, Coglianese A, Izzo B. Development and validation of a reverse-phase high-performance liquid chromatography with fluorescence detection (RP-HPLC-FL) method to quantify Ruxolitinib in plasma samples. Anal Lett. 2019;52(8):1328-39. doi: 10.1080/00032719.2018.1537283.

Biswal S, Mondal S, Mondal P. A new stability indicating high performance liquid chromatography method for the estimation of Ruxolitinib in bulk and tablet dosage form. Pharm Methods. 2019;10(2):53-7. doi: 10.5530/phm.2019.2.10.

Dousa M, Doubsky J, Gajdosova M, Tkadlecova M, Martinu T, Jires J. Detection and structure elucidation of the new degradation impurities in the pharmaceutical formulations of Ruxolitinib hydrobromide. J Pharm Biomed Anal. 2020;186:113266. doi: 10.1016/j.jpba.2020.113266, PMID 32348952.

Di Michele A, Schoubben A, Varfaj I, D’Arpino A, Mercolini L, Sardella R. Improved achiral and chiral HPLC-UV analysis of Ruxolitinib in two different drug formulations. Separations. 2020;7(3):47. doi: 10.3390/separations7030047.

Chawla G, Ranjan C. Principle, instrumentation, and applications of UPLC: A novel technique of liquid chromatography. CHEM. 2016;3(1):1-16. doi: 10.2174/1874842201603010001.

Tutor. Pharma analysis. Pharmacia. Available from: https://www.pharmatutor.org/pharma-analysis. [Last accessed on 05 Dec 2022]

Sapkota A, Komal. Types of chromatography (definition, principle, steps, uses). Microbe Notes. 2022. Available from: https://microbenotes.com/types-of-chromatography. [Last accessed on 05 Dec 2022]

Bandla J, Ganapaty S. New stability-indicating ultra performance liquid chromatography method development and validation of lenvatinib mesylate in bulk drug and pharmaceutical dosage forms. Asian J Pharm Clin Res. 2018;11(9):140. doi: 10.22159/ajpcr.2018.v11i9.26766.

Rupal JS, Prajapati AK, Snehasamir B, Kazoomi P, Neha AS, Nidhi P. Utility of platelet indices in thrombocytopenia. Asian J Pharm Clin Res. 2022:163-6.

Suvasish M, Koushik S, Avijit G, Abhijit Saha, Subrata S. A validated stability indicating RP-HPLC method for estimation of avapritinib in bulk and tablet dosage form. Int J Appl Pharm. 2022:95-101.

Ayman A, Abdullakhalid N, Hana M, Patricka B. Janus kinase enzyme (JAK) inhibitors and rheumatoid arthritis: a review of the literature. Int J Curr Pharm Res. 2019:11-4.