RP- HPLC Method Development And Validation of Acalabrutinib In Bulk And Formulation & Greenness Assessment of Developed Method.

  • Bhavesh D.Mahajan
  • Dr.Ashish S Jain
  • Dr.Reshma V. Jadhav
  • Prathamesh V. Chaudhari
  • Priya Jagtap
  • Prapti Gawand
  • Aishwarya Patil
Keywords: Acalabrutinib, RP-HPLC, ICH Q2 (R1) guidelines, %RSD, Greenness tools

Abstract

The present study was develop to asses a greenness approach for method development and validation  which were verified for linearity, sensitivity, accuracy, precision, specificity, and robustness as per ICH guidelines. A simple UV method was develop & employed using acetonitrile as a diluent at a wavelength of 228nm. The linearity range was observed from 0-20 µg mL-1 with a correlation coefficient of 0.9993. The developed method was robust & precise with a %RSD value less than 2 for both intra-day (1.46%) and inter-day (1.52%) precision and results were statistically analyzed according to the ICH Q2 (R1) guidelines. Acalabrutinib was effectively separated using a HiQsil RP C18, 5 µm, 250 mmx4.6 mm i.d. column in an isocratic method of separation, utilizing Acetonitrile: water in the ratio of 75:25% v/v, with a flow rate of 1.0 mL/min and detection at 228 nm. The response was found to be linear in the drug concentration range of 0-50 µg mL-1 for Acalabrutinib. The correlation coefficient for (RP-HPLC) was found to be 0.9998 for Acalabrutinib. The value of 1.0438 µg mL-1 and 3.1630 µg mL-1 for LOD and LOQ for Acalabrutinib were found. The given approach demonstrated good % recovery for Acalabrutinib, indicating that it is very accurate. The method's specificity demonstrates a strong correlation between the retention times of the standard and sample solutions. As a result, the demonstrated approach precisely detects the analyte in the bulk sample with no interference from pharmaceutical dosage form excipients.The greeness of method was evaluated by tools like HPLC_EAT,AGREE, GAPI & COMPLEX GAPI.

Author Biographies

Bhavesh D.Mahajan

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra   410206

Dr.Ashish S Jain

Principal, Shri D.D. Vispute College of Pharmacy and Research Center, Devad, Vichumbe, Gut No. 104, Adjacent to Mumbai-Pune Express Highway, Tal. Panvel, Dist-Raigad, Pincode-410221, Maharashtra, India

 

Dr.Reshma V. Jadhav

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra 410206

Prathamesh V. Chaudhari

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra 410206

Priya Jagtap

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra 410206

Prapti Gawand

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra 410206

Aishwarya Patil

Shri D. D. Vispute College Of Pharmacy & Research Center Panvel Mumbai Maharashtra 410206

References

1. Bathula AY, V. K :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 2023: .INDIA.
2. Byrd, J. C.; Harrington, B.; O’Brien et al: Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia: N. Engl. J. Med. 2016, 374 (4), 323–332. https://doi.org/10.1056/nejmoa1509981.
3. Markham. A.; Dhillon, S. Acalabrutinib: First Global Approval. Drugs 2018: 78 (1), 139–145. https://doi.org/10.1007/s40265-017-0852-8.
4. Rasmuson, R. S. V. S: Ketoprofen Solubility in Pure Organic Solvents Using In Situ FTIR and UV–Vis and Analysis of Solution Thermodynamics; Organic process research & development, 2021.
5. Sundararajan, O. M: Development And Validation Of UV Spectrophotometric Method For Determination Of Acalabrutinib; Ymer || Issn : 0044-0477, 2022 Volume 21, 6 (June).
6. K. Kriegsmann, M. Kriegsmann and M. Witzens-Hari, “Acalabrutinib, a second-generation bruton's tyrosine kinase inhibitor”, Recent. Results. Cancer. Res. (2018),212:285-294.
7. P. Prathyusha & S. Raja, “UV spectrophotometric method for determination of bilastine in bulk and pharmaceutical formulation”, Res. J. Pharm. Technol. (2020), 13(2): 933-938
8. Sahu, P. K.; Ramisetti, N. R.; Cecchi, T.; Swain, S.; Patro, C. S.; Panda, J. An Overview of Experimental Designs in HPLC Method Development and Validation: J. Pharm. Biomed. Anal. 2018, 147, 590–611. https://doi.org/10.1016/j.jpba.2017.05.006.
9. Puri M, Walia YK. RP-HPLC Analysis of Clopidogrel Bisulphate in Pharmaceutical Dosage form: Method Development and Validation. Research Journal of Pharmacy and Technology. 2024; 17(7):3109-4. doi: 10.52711/0974-360X.2024.00486.
10. More S, Ghodekar S, Jadhav V, Jain A. HPLC – high performance liquid chromatography & uplc – ultra performance liquid chromatographic system – a review on modern liquid chromatography; indo american journal of pharmaceutical sciences, 2018.
11.Walfish, S. Analytical Methods: A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods; BioPharm International journal, 2006.
12. Sravani A, Manichandrika P, Rani Sarutha et. : Method Development & Validation Of Acalabrutinib in Pure Form & Pharamceutical Dosage Form by RP-HPLC. Journal Of Innovative Development In pharmaceutical & technical sceince.2024:7-9.
13.ICH harmonised tripartite guideline impurities in new drug substances, Q3A(R2), 2006.
14. Patel, S. R. A. S. Development, Validation and Greenness Assessment of Stability Indicating RP-HPLC Method for Simultaneous Quantification of Dapagliflozin and Metoprolol Succinate in Synthetic Mixture. International Journal of Pharmaceutical Sciences and Drug Research 2024, 16 (6), 975–982.
15.Gamal, M.; Naguib, I. A.; Panda, D. S.; Abdallah, F. F. Comparative Study of Four Greenness Assessment Tools for Selection of Greenest Analytical Method for Assay of Hyoscine N-Butyl Bromide. Anal. Methods 2021, 13 (3), 369–380. https://doi.org/10.1039/d0ay02169e.
16.Płotka-Wasylka, J. A New Tool for the Evaluation of the Analytical Procedure: Green Analytical Procedure Index. Talanta 2018, 181, 204–209. https://doi.org/10.1016/j.talanta.2018.01.013.
Published
2024-06-25
How to Cite
Bhavesh D.Mahajan, Dr.Ashish S Jain, Dr.Reshma V. Jadhav, Prathamesh V. Chaudhari, Priya Jagtap, Prapti Gawand, & Aishwarya Patil. (2024). RP- HPLC Method Development And Validation of Acalabrutinib In Bulk And Formulation & Greenness Assessment of Developed Method. Revista Electronica De Veterinaria, 25(1), 3389 -3402. https://doi.org/10.69980/redvet.v25i1.1579
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Articles