Volume : 13, Issue : 06, June – 2026

Title:

METHOD DEVELOPMENT AND VALIDATION OF A ZERO-ORDER UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF APIXABAN

Authors :

Dr. Naveen Kumar G S, Jashwanth Gowda H U*

Abstract :

A simple, accurate, and precise zero order derivative UV spectroscopic method has been devised and validated for the estimation of Apixaban in bulk and tablet dosage form. According to Beer’s law, the concentration of Apixaban in methanol ranges from 4 to 24 µg/ml, and its absorbance reaches its maximum at 280 nm. The area under the curve in absorption spectra is measured between 275 and 285 nm. The regression coefficient (r2) was found to be 0.999 following a linearity investigation, demonstrating acceptable linearity and precision over this concentration range. The percentage recovery was found to be 99.2%, 101%, and 99.6%, while the limits of detection (LOD) and quantitation (LOQ) were found to be 1.09 and 3.3 micrograms per milliliter, respectively. Furthermore, excellent precision was indicated by the methodologies’ relative standard deviation (% RSD) values, which were less than 2%. All validation metrics, including linearity, accuracy, precision, ruggedness, LOD, and LOQ, were assessed in accordance with ICH requirements. The developed and proven method can be used to regularly estimate the dosage of Apixaban in both bulk and tablet form.
KEYWORDS: Apixaban ;Quantification;Validation; RP-HPLC; HPTLC, Anticoagulant.

Cite This Article:

Please cite this article in press Jashwanth Gowda H U et al., Method Development And Validation Of A Zero-Order Uv Spectrophotometric Method For Determination Of Apixaban.., Indo Am. J. P. Sci, 2026; 13(06).

REFERENCES:

1. Jain HK, Nikam VK. Formulation development and stability indicating HPLC assay of tablets of apixaban. Int J Pharm Pharm. Sci. 2017 Oct 2;9:24-32.
2. Chitale AS, Hamrapurkar P. Development and validation of assay method for estimation of Apixaban in bulk drug and its marketed formulation. International Journal of Advance Research, Ideas and Innovations in Technology. 2018;4(6):367-70.
3. Anusha K, Sowjanya G, Ganapaty S. Development and validation of uv spectrophotometric methods for apixaban in tablets. Eur. J. Biomed. Pharm. Sci. 2018;5:929-33.
4. Mahendra B, Sundari KH, Vimalakkannan T. Method developed for the determination of apixaban by using UV spectrophotometric. International Journal of Research In Pharmaceutical Chemistry and Analysis. 2019 Jul 29;1(3):83-7.
5. BOGGULA N, HAQUE A, BAKSHI V, GANGARAPU K. Method development and validations of Apixaban in bulk and its formulations by UV-spectroscopy (area under curve). Journal of Chemical and Pharmaceutical Analysis. 2017;4(3):1-1..
6. Radhika AG, Singh A, Sowmya A, Haque A, Bakshi V, Boggula N. Comparative studies of apixaban in bulk and its formulations by Uv-Spectroscopy (Zero Derivatives and Area Under Curve). Int. J. Pharm. Biol. Sci. 2018;8:1002-8.
7. Prabhune SS, Jaguste RS, Kondalkar PL, Pradhan NS. Stability-indicating high-performance liquid chromatographic determination of Apixaban in the presence of degradation products. Scientia pharmaceutica. 2014 May 22;82(4):777.
8. Rajput RS, Lariya N. A stability indicating method development and validation of apixaban in pharmaceutical dosage form by using RP-HPLC and in-vitro evaluation of apixaban suspension delivery through enteral feeding tubes. Journal of Medical Pharmaceutical and Allied Sciences. 2022;11(1):4358-63.
9. Gosar A, Phadke R, Patil D, Gupta K, Thakur P. Development and validation of an new high performance liquid chromatography method for determination of apixaban isomers. CBE. 2020;5(1):20-7.
10. Al-Ani I, Hamad M, Al-Shdefat R, Mansoor K, Glogor F, Dayyish WA. Development and validation of stability indicating RP-HPLC method of apixaban in commercial dosage forms. International Journal of Pharmaceutical Sciences and Research. 2019;12(1):241-51.
11. Erten Akbel*, İbrahim Bulduk, and Süleyman Gökçe A green HPLC method for the determination of apixaban in pharmaceutical products: Development and validation
12. Shaikh AN, Sonawane AS, Khan MA. Analytical Method Development and Validation of Apixaban by RP-HPLC. J. Res. Pharmaceut. Sci. 2022;8:01-14.
13. dos Santos NO, Wingert NR, Steppe M. Dissolution Profile of Apixaban Tablets: Method Development and Validation Using HPLC Analysis. Dissolution Technologies. 2022 Feb 1;29(1):22-7.
14. Shukla R, Chaudhari A, Patel P, Detholia K. QbD-based RP-HPLC method development for quantitative computation of phase III composition comprising apixaban and clopidogrel. Journal of Applied Pharmaceutical Science. 2024 Aug 5;14(8):085-93.
15. Damle MC, Waghmare SS, Sinha PU. Development and validation of stability-indicating HPTLC method for determination of apixaban as bulk drug. Int J Pharm Pharm Sci. 2019;11:37-42.
16. Lagoutte-Renosi J, Le Poupon J, Girard A, Montange D, Davani S. A simple and fast HPLC-MS/MS method for simultaneous determination of direct oral anticoagulants apixaban, dabigatran, rivaroxaban in human plasma. Journal of Chromatography B. 2018 Nov 15;1100:43-9.
17. El-Bagary RI, Elkady EF, Farid NA, Youssef NF. Validated spectrofluorimetric methods for the determination of apixaban and tirofiban hydrochloride in pharmaceutical formulations. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2017 Mar 5;174:326-30.
18. ICH, Q2A text on validation of analytical procedures; 1994.
19. ICH, Q2B validation of analytical methodology; 1996.
20. ICH, Q2 (R1) validation of analytical procedures: text and methodology; 2005.