Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations

Yıl 2022, Cilt: 9 Sayı: 2, 505 - 512, 31.05.2022

Mehmet Emrah Yaman Alptuğ Atila Yücel Kadıoğlu

https://doi.org/10.18596/jotcsa.956110

Öz

The development and validation of a novel, simple, and quick HPLC technique for measuring bosentan in pharmaceutical formulations was performed. The technique parameters were tuned to be 1 mL/min flow rate, variable column temperature, and a mobile phase combination of methanol-acetonitrile-water (20:50:30 v/v/v) to carry out this study. All measurements were carried out with a UV detector at a wavelength of 272 nm. Specificity, the limit of quantitation (LOQ), limit of detection (LOD), linearity, accuracy, precision, stability, recovery, and ruggedness were all tested. The technique was linear between 0.25 and 20 µg/mL, with precision (RSD%) and accuracy (RE%) of less than 3.0 and 2.7%, respectively. The LOQ and LOD values of method were 0.25 and 0.1 µg/mL, respectively. The 10 µg/mL of standard bosentan solution was found to be moderately stable in acidic and basic settings (0.1 M HCl and 0.1 M NaOH) but unstable in an oxidative environment (H2O2 solution; 3%). No interference from tablet excipients was observed in the HPLC method. The approach was successfully applied to pharmaceutical formulations obtained from a local pharmacy store.

Anahtar Kelimeler

Bosentan, HPLC analysis, Drug degradation, Bioanalytical Method Validation

Kaynakça

• 1. Motte S, McEntee K, Naeije R. Endothelin receptor antagonists. Pharmacology & Therapeutics. 2006 Jun;110(3):386–414.
• 2. Clozel M, Breu V, Gray GA, Kalina B, Löffler B, Burri K, et al. Pharmacological characterization of bosentan, a new potent orally active nonpeptide endothelin receptor antagonist. Journal of Pharmacology and Experimental Therapeutics. 1994;270(1):228–35.
• 3. Rubin LJ, Badesch DB, Barst RJ, Galiè N, Black CM, Keogh A, et al. Bosentan Therapy for Pulmonary Arterial Hypertension. N Engl J Med. 2002 Mar 21;346(12):896–903.
• 4. Azim MS, Husain A, Mitra M, Bhasin PS. Pharmacological and pharmaceutical profile of Bosentan: A review. Am J Pharm Tech Res. 2012;4:135–47.
• 5. Weber C, Gasser R, Hopfgartner G. Absorption, excretion, and metabolism of the endothelin receptor antagonist bosentan in healthy male subjects. Drug metabolism and disposition. 1999;27(7):810–5.
• 6. Lavudu P, Rani AP, Chander AP, Sekaran CB. Determination of bosentan in pharmaceutical dosage forms by high performance liquid chromatography. International Journal of Drug Delivery. 2013;5(2):146.
• 7. Muralidharan S, Kumar JR. Simple estimation of bosentan in tablet formulation by RP-HPLC. American Journal of Analytical Chemistry. 2012;3:715.
• 8. Shahul HM, Jat RK, Indulatha VN. Method development and its validation for quantitative determination of bosentan in tablet dosage form by RP-HPLC. J Drug Delivery Ther. 2017 Mar 15;7(2):85–95.
• 9. Saidulu P, Masthanamma SK, Kumari VA. New validated RP-HPLC method for the determination of bosentan in bulk and dosage form. Research Journal of Pharmacy and Technology. 2015 May;8(5):549–53.
• 10. Annapurna M, Pavani S, Anusha S, Harika M. Validated stability indicating RP-HPLC method for The determination of bosentan in presence of degradation products. Indo American Journal of Pharmaceutical Research. 2013;3(6):4528–40.
• 11. Kumar AA, Kumar A, Sankar DG. Development, estimation and validation of prasugrel in bulk and in its pharmaceutical formulation by UV-Vis spectroscopic method. Pharmanest. 2011;2(1):37–9.
• 12. Narendra A, Deepika D, Annapurna MM. New Spectrophotometric Method for the Determination of Bosentan - An Anti-Hypertensive Agent in Pharmaceutical Dosage Forms. E-Journal of Chemistry. 2012;9(2):700–4.
• 13. Das S, Narendra A, Kumar VR, Annapurna MM. Validated new spectrophotometric methods for the estimation of bosentan in bulk and pharmaceutical dosage forms. Journal of Pharmaceutical Education & Research. 2010;1(2):73–6.
• 14. Lavudu P, Rani AP, Sekaran CB, Ramesh A, Kumar A. Application of spectrophotometry and high performance liquid chromatography for the analysis of Bosentan in pharmaceutical dosage form. Chem Sci Transaction. 2014;3(4):1242–53.
• 15. Pavani B, Harshavardhan B, Sindhu P, Saharanya K. Method development and validation of bosentan by UV-Spectrophotometric Method. Journal of Drug Development and Delivery. 2018;1:34–8.
• 16. Suganthi A, Lakshmi S, Vinod S, Ravi T. Development and validation of UV spectroscopic and HPTLC methods for the determination of Bosentan from tablet dosage form. Sch Acad J Pharm. 2014;3(2):123–7.
• 17. Atila A, Yilmaz B. Determination of bosentan in pharmaceutical preparations by linear sweep, square wave and differential pulse voltammetry methods. Iran J Pharm Res. 2015;14(2):443–51. PMID: 25901151.
• 18. Bakshi M, Singh S. Development of validated stability-indicating assay methods—critical review. Journal of Pharmaceutical and Biomedical Analysis. 2002 Jun;28(6):1011–40.
• 19. Jadhav SA, Landge SB, Jadhav SL, Niphade NC, Bembalkar SR, Mathad VT. Stability-indicating gradient RP-LC method for the determination of process and degradation impurities in bosentan monohydrate: An endothelin receptor antagonist. Chromatography Research International. 2011;2011:1–9.
• 20. Khan MA, Sinha S, Todkar M, Parashar V, Swamy K. Development and validation of a stability indicating analytical method for the related substances of Bosentan drug substance by HPLC. Ame J Scien Ind Res. 2012;3(2):69–80.
• 21. Anonymous. ICH Topic Q 1 A (R2) Stability Testing of New Drug Substances and Products, European Medicines Agency, CPMP/ICH/2736/99. ICH; 2003.
• 22. Anonymous. ICH Q2B Guideline Validation of Analytical Procedures: Methodology, (International Conference on Harmonization of Technical Requirements for the Registration of Drugs For Human Use. ICH; 1997.