Articles
Hikal H.O., Nighenkovska I.V., Glushachenko O.O., Markin R.O., Syrotchuk O.A. Aspects of developing an eco-friendly method for determining azilsartan medoxomil using high-performance liquid chromatography
UDC 543.544.5.068.7;615.074
DOI:
Hikal H.O., Nighenkovska I.V., Glushachenko O.O., Markin R.O., Syrotchuk O.A.
Aspects of developing an eco-friendly method for determining azilsartan medoxomil using high-performance liquid chromatography
The article examines the peculiarities of using aqueous-ethanol solutions for chromatography of azilsartan medoxomil with the perspective of further developing an eco-friendly method for determining the active component in finished pharmaceutical formulations. The influence of pH on the UV spectrum has been investigated, and the optimal wavelength for spectrophotometric detection has been determined to be 250 nm. Depending on the pH of the mobile phase in reverse- phase mode, retention factors decrease in the selected pH range of 2.0, 4.0, and 7.0, amounting to 13.0, 11.9, and 1.7 respectively. Retention factors, efficiency have been established when varying the organic component content in the mobile phase from 50 to 80% v/v. It has been shown that the retention factor decreases from 11.9 to 0.8 with such variation in ethanol content in the mobile phase. Stability and solubility of azilsartan medoxomil in eco-friendly solvents have been examined at room temperature and when stored in a refrigerator. It has been found that the stability of azilsartan medoxomil in 96% ethanol increases when stored at a temperature of 5°C compared to room temperature, and higher stability is demonstrated when using absolute ethanol as a solvent. The obtained data indicate the possibility of developing an eco-friendly method using ethanol in the mobile phase and as a solvent for sample preparation.
Keywords: azilsartan medoxomil, liquid chromatography, ethanol, green analytical chemistry.
REFERENCES
1. W. L. Baker and W. B. White. “Azilsartan Medoxomilo: Un Antagonista de los Receptores de Angiotensina II Nuevo para el Tratamiento de Hipertensión.” Ann. Pharmacother. 2011. vol. 45. no. 12. pp. 1506–1515. doi: 10.1345/aph.1Q468.
2. W. M. Ebeid. E. F. Elkady. A. A. El-Zaher. R. I. El-Bagary. and G. Patonay. “Stability- indicating RP-LC method for determination of azilsartan medoxomil and chlorthalidone in pharmaceutical dosage forms: Application to degradation kinetics.” Anal. Bioanal. Chem. 2014. vol. 406. N. 26. pp. 6701–6712. doi: 10.1007/s00216-014-8085-0.
3. M. Kher. V. Bhatt. A. Jani. and N. Sheth. “Development and Validation of Stability Indicating Chromatographic Methods for Determination of Azilsartan Medoxomil in Pharmaceutical Formation.” Anal. Chem. Lett. 2020. vol. 10. N 3. pp. 387–401. 2020. doi: 10.1080/22297928.2020.1784788.
4. P. P. Vekariya and H. S. Joshi. “Development and Validation of RP-HPLC Method for Azilsartan Medoxomil Potassium Quantitation in Human Plasma by Solid Phase Extraction Procedure.” ISRN Spectrosc. 2013 Sep.. .V. 2013. pp. 1–6. . doi: 10.1155/2013/572170.
5. O. S. S. Chandana and R. Ravichandrababu. “Stability Indicating RP-HPLC Method for Azilsartan Related Substances in Solid Dosage Forms,” 2017. [Online]. Available: www.rsisinternational.org.
6. Y. Parihar. T. Kotkar. M. P. Mahajan. and S. D. Sawant. “Development and validation of RP-HPLC method for simultaneous estimation of telmisartan and cilnidipine in bulk and tablet dosage form.” Pharmanest. V. 5. no. 5. pp. 2321–2325. 2014.
7. Ł. Czubak, A. Krygier, and B. T. Małecka, “Gas Chromatography Method of Cleaning Validation Process for 2- Propanol Residue Determination in Pharmaceutical Manufacturing Equipment,” 2014. vol. 6, no. 3, P.. 243–245.
8. Z. B. Todorović, M. L. Lazić, V. B. Veljković, and D. M. Milenović, “Validation of an HPLC-UV method for the determination of digoxin residues on the surface of manufacturing equipment,” J. Serbian Chem. Soc. 2009. vol. 74, no. 10, P.. 1143–1153, , doi: 10.2298/JSC0910143T.
9. L. Liu and B. W. Pack, “Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: Strategy, validation, and long-term performance,” J. Pharm. Biomed. Anal.2006. vol. 43, no. 4, P.. 1206–1212, 2007, doi: 10.1016/j.jpba.2006.10.008.