ABSTRACT:
Acalabrutinib is an anti-cancer drug used for metastatic prostate cancer treatment. A new stability indicating RP-HPLC method was developed and validated for the determination of Acalabrutinib in tablets. Shimadzu HPLC Model no. iSeries 2050C 3D with Lab solutions Software with PDA detector and Shim-pack GIST C18 column (250 x 4.6 mm, 5m) were used for the present study. A mixture of 0.02M of Ammonium acetate (pH adjusted to 4.0 with glacial acetic acid) and Acetonitrile (50: 50, v/v) was used as mobile phase with flow rate 1.0 mL/min were the optimised chromatographic conditions (Detection wavelength 285 nm). The method was linear over the concentration range 0.2-150 mg/ml with linear regression equation, y = 18135x + 1732.4 (R² = 0.9998). The LOQ and LOD were found to be 0.1932 mg/ml and 0.06354 respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.
Cite this article:
Hema, Naresh Panigrahi. A new stability indicating RP-HPLC method for the estimation of Acalabrutinib. Research Journal of Pharmacy and Technology. 2025;18(5):2349-5. doi: 10.52711/0974-360X.2025.00336
Cite(Electronic):
Hema, Naresh Panigrahi. A new stability indicating RP-HPLC method for the estimation of Acalabrutinib. Research Journal of Pharmacy and Technology. 2025;18(5):2349-5. doi: 10.52711/0974-360X.2025.00336 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-5-59
REFERENCES:
1. Wu J, Zhang M, Liu D: Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016; 9: 21.
2. Cheah CY, Seymour JF, Wang ML: Mantle Cell Lymphoma. J Clin Oncol. 2016; 34(11): 1256-1269.
3. Mohamed WA, Ahmed HB, Ali SA and Adnan AK. An Ultrafast UPLC-MS/MS method for characterizing the in vitro metabolic stability of Acalabrutinib. Molecules. 2023; 28(20): 7220.
4. Bhoopendra Singh K, Hara Prasad P, Rahul K, Vijaya MG, Vinay Kumar K, Rajesh Sonti and Gananadhamu S. Structural characterization of novel hydrolytic and oxidative degradation products of Acalabrutinib by LC-Q-TOF-MS, H/D exchange and NMR. Journal of Pharmaceutical and Biomedical Analysis. 2022; 221: 115077.
5. Venkat Rao V, Naresh Kumar K, Chirag K, Pankaj K, Srinivasa Rao P and Sreekanth Babu J. A novel LC-MS/MS method for simultaneous estimation of Acalabrutinib and its active metabolite Acalabrutinib M27 in human plasma and application to a human pharmacokinetic study. RSC Advances. 2022; 12(11): 6631-6639.
6. Shweta Mishra and Ashlesha Chauhan. LC-MS/MS and NMR studies for identification and characterization of forced degradation products of Acalabrutinib. Ind. J. Pharm. Edu. Res. 2023; 57(3):864-872.
7. Atchutarama Krishna G, Srinivasarao P, Benarji Patrudu T and Chidanandaswamy R. Development and validation of novel HPLC bioanalytical analysis method for Acalabrutinib: An anticancer drug in human plasma. Asian Journal of Chemistry. 2020; 32(10): 2606-2610.
8. Anusha A, Pushpa Latha E, Uttam Prasad Panigrahy, Rama Mohan Reddy T and Abbulu K. Stability indicating RP-HPLC method development and validation for the determination of Acalabrutinib in bulk drug and capsule dosage form. International Journal of Bio-Pharma Research. 2019; 8(8): 2758-2762.
9. Sayali Thakekar, Bharti Fegade, Madhuri Jadhav, Vijaya Kumar Munipalli, Raman Mohan Singh and Vaidhun Bhaskar. method development and validation for quantitative estimation of Acalabutinib in capsule dosage form by RP-HPLC Method. International Journal of Pharmacy and Pharmaceutical Research. 2022; 23(2): 34-46.
10. Bathula Anusha Yadav and Vijaya Kuchana. Analytical method development and validation for the estimation of Acalabrutinib in API form and marketed pharmaceutical dosage form by RP-HPLC along with stability studies. International Journal of Multidisciplinary Research and Growth Evaluation. 2024; 5(1): 83-92.
11. Venu GK, Sujatha M and Guna BD. Novel stability indicating high-performance liquid chromatography method for the separation and simultaneous quantification of Acalabrutinib and its impurities in pharmaceutical formulation. Analytical Science and Technology. 2023; 36(1): 32-43.
12. Oindrila Mazumder and Raja Sundararajan. analytical method development and validation for determination of Acalabrutinib by using RP-HPLC. YMER. 2022; 21(7): 922-940.
13. Priyanka P, Shyamala, Mounika D, Nadeemuddin and Abdul Moyeez. Development and validation of RP-HPLC method for determination of new anticancer agent Acalabrutinib in bulk and its pharmaceutical formulation. European Journal of Biomedical and Pharmaceutical Sciences. 2019; 6(4): 465-470.
14. Rayala VVSPK, Trivedi KA, Upadhyayula SM, Gunnam S, Borkar RM and Radhakrishnanand P. A validated chiral chromatographic method for the enantiomeric separation of Acalabrutinib. Chirality. 2022; 34(9): 1247-1256.
15. ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology (2005).
16. ICH Q1A (R2) Stability Testing of New Drug Substances and Products (2003).