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Stream/Area:
-
Subject:
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Paper ID:
IJSREM66674
Volume:
10 |
8 |
Aug 2026
Pages:
1-7
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
Pharmaceutical Analysis
Sri Vijay Vidyalaya College of Pharmacy
Pharmaceutical Analysis
Sri Vijay Vidyalaya College of Pharmacy
Pharmaceutical Analysis
Sri Vijay Vidyalaya College of Pharmacy
Pharmaceutical Analysis
Sri Vijay Vidyalaya College of Pharmacy
M. Pharm
Sri Vijay Vidyalaya College of Pharmacy Nallampalli Post and Taluk, Dharmapuri District, Tamil Nadu, 636807.
Macitentan, a dual endothelin receptor antagonist, and Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, are increasingly co-administered as combination pharmacotherapy for pulmonary arterial hypertension (PAH). Because a dedicated, comparative UV spectrophotometric profile for the two agents is not extensively documented, the present study was undertaken to characterise and compare their UV absorption behaviour under identical experimental conditions. Working solutions of Macitentan and Sildenafil (50 µg/mL in methanol) prepared from marketed tablet formulations were scanned individually over 200–400 nm using a UV-Visible spectrophotometer with methanol as blank. Macitentan showed a characteristic absorption maximum (λmax) at 222 nm (absorbance 2.888), while Sildenafil showed λmax at 228 nm (absorbance 3.420), a bathochromic shift of 6 nm. Sildenafil displayed a broader absorption range (200–358 nm; width 158 nm) than Macitentan (200–330 nm; width 130 nm), a wider full width at half maximum (48.5 nm vs. 31.8 nm), and approximately 18.4% higher absorbance intensity at its respective λmax. Both drugs obeyed the Beer–Lambert law over 10–50 µg/mL, with Macitentan showing marginally superior linearity (r = 0.9917, R² = 0.9835) compared with Sildenafil (r = 0.9760, R² = 0.9525). The distinct spectral fingerprints obtained provide a scientific basis for selecting drug-specific analytical wavelengths and support the future development of a simple, rapid, and economical UV spectrophotometric method for the routine quality control of Macitentan–Sildenafil combination formulations.
KEYWORDS
A comparative UV spectrophotometric study of Macitentan and Sildenafil in tablet formulations was carried out under identical experimental conditions using methanol as solvent. The two drugs showed clearly distinguishable UV absorption profiles: Macitentan exhibited λmax at 222 nm with narrower and less intense absorption, while Sildenafil exhibited λmax at 228 nm with a broader, more intense, and more extended absorption profile. Both drugs obeyed the Beer–Lambert law over 10–50 µg/mL, confirming the applicability of UV spectrophotometry for their quantitative estimation. These findings establish a scientific basis for the selection of analytical wavelengths and support the future development of a simple, rapid, precise, and economical UV spectrophotometric method for the routine quality control — including assay, content uniformity, and dissolution testing — of Macitentan and Sildenafil, individually or as combination formulations, in academic and small- to medium-scale pharmaceutical quality-control laboratories.
1) International Conference on Harmonisation (ICH). Q2(R1): Validation of Analytical Procedures: Text and Methodology. Geneva: ICH; 2005. 2) US Food and Drug Administration. Opsumit (macitentan) tablets: prescribing information. Silver Spring (MD): FDA; 2013. 3) US Food and Drug Administration. Revatio (sildenafil) tablets: prescribing information. Silver Spring (MD): FDA; 2005. 4) Patil DR, Neve TD. Development and Validation of UV-Spectrophotometric Method for Macitentan Bulk Drug and Formulation. International Journal of Pharma Research and Technology. 2022;1(1):1–7. 5) Kocak OF. A New Spectrophotometric Method for the Determination of Macitentan in Human Plasma. Natural Products and Biotechnology. 2022;2(2):74–80. 6) Lakka NS, Kuppan C, Rangasamy P. Impurity profile of macitentan in tablet dosage form using a stability-indicating high performance liquid chromatography method and forced degradation study. Journal of Pharmaceutical Analysis. 2019. doi:10.3724/SP.J.1123.2018.06032. 7) Sabbani Ranjith Kumar M. Analytical Method Development and Validation of Macitentan and Tadalafil Using RP-HPLC in Bulk and Tablet Formulations. World Journal of Pharmaceutical Sciences. 2025;13(3). 8) Lusina M, et al. Analytical approaches for the determination of endothelin receptor antagonists in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis. 9) Kocak OF, et al. Analytical determination of endothelin receptor antagonist drugs using spectrophotometric approaches. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 10) Katsuki Y, et al. Analytical investigation of macitentan and its related substances in pharmaceutical formulations. Journal of Pharmaceutical Sciences.
Publication Date
8/11/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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