Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry

P Ravisankar; Mukkanti Eswarudu Munnangi; Jasvitha Mandava; Vasudha Dadı

doi:10.52794/hujpharm.1789440

Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry

Abstract

The primary aim of the current investigation was the Analytical progression and validation of a UV-spectrophotometric analytical approach for the quantification of Nirogacestat in both bulk and pharmaceutical dosage forms, in alignment with ICH regulatory standards. A straightforward, expeditious, reliable, and economically viable UV-spectrophotometric technique was established for the quantitative determination of Nirogacestat employing acetonitrile as the solvent medium. The absorbance of the analyte solution was recorded at 269 nm relative to a suitable blank. Method validation was performed pursuant with prescribed parameters, encompassing linearity, accuracy, precision and robustness. The λmax of Nirogacestat in acetonitrile was identified at 269 nm. The analyte demonstrated compliance with Beer-Lambert’s law across the concentration interval of 2.5–15.0 μg/mL, exhibiting a correlation coefficient(R²) of 0.999. The percentage recovery ranged from 99.3% to 100.1% reflecting substantial accuracy. Precision assessments resulted %RSD values below 2.0, substantiating both repeatability and intermediate precision. Robustness evaluations involving minor alterations in wavelength exhibited negligible deviation, thereby affirming reliability. Additionally, forced degradation experiments substantiated the stability-indicating characteristics. The delineated UV-spectrophotometric technique is straightforward, analytically sensitive, and reproducible. It is eminently suitable for routine quality assessment and quantitative evaluation of Nirogacestat in bulk drug substances and tablet formulations.

Keywords

References

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Details

Primary Language

English

Subjects

Medical Pharmacology

Journal Section

Research Article

Authors

P Ravisankar
0000-0003-4450-5732
India

Mukkanti Eswarudu Munnangi
0000-0002-2685-4739
India

Jasvitha Mandava
0009-0009-8945-3316
India

Vasudha Dadı ^*
0000-0003-3862-0590
India

Publication Date

September 1, 2026

Submission Date

September 23, 2025

Acceptance Date

August 4, 2026

Published in Issue

Year 2026 Volume: 46 Number: 3

DOI

https://doi.org/10.52794/hujpharm.1789440

IZ

https://izlik.org/JA97RD85EE

Cite

RIS / Bibtex

APA

Ravisankar, P., Munnangi, M. E., Mandava, J., & Dadı, V. (2026). Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry. Hacettepe University Journal of the Faculty of Pharmacy, 46(3), 233-240. https://doi.org/10.52794/hujpharm.1789440

AMA

1.Ravisankar P, Munnangi ME, Mandava J, Dadı V. Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry. HUJPHARM. 2026;46(3):233-240. doi:10.52794/hujpharm.1789440

Chicago

Ravisankar, P, Mukkanti Eswarudu Munnangi, Jasvitha Mandava, and Vasudha Dadı. 2026. “Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry”. Hacettepe University Journal of the Faculty of Pharmacy 46 (3): 233-40. https://doi.org/10.52794/hujpharm.1789440.

EndNote

Ravisankar P, Munnangi ME, Mandava J, Dadı V (September 1, 2026) Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry. Hacettepe University Journal of the Faculty of Pharmacy 46 3 233–240.

IEEE

[1]P. Ravisankar, M. E. Munnangi, J. Mandava, and V. Dadı, “Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry”, HUJPHARM, vol. 46, no. 3, pp. 233–240, Sept. 2026, doi: 10.52794/hujpharm.1789440.

ISNAD

Ravisankar, P - Munnangi, Mukkanti Eswarudu - Mandava, Jasvitha - Dadı, Vasudha. “Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry”. Hacettepe University Journal of the Faculty of Pharmacy 46/3 (September 1, 2026): 233-240. https://doi.org/10.52794/hujpharm.1789440.

JAMA

1.Ravisankar P, Munnangi ME, Mandava J, Dadı V. Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry. HUJPHARM. 2026;46:233–240.

MLA

Ravisankar, P, et al. “Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry”. Hacettepe University Journal of the Faculty of Pharmacy, vol. 46, no. 3, Sept. 2026, pp. 233-40, doi:10.52794/hujpharm.1789440.

Vancouver

1.P Ravisankar, Mukkanti Eswarudu Munnangi, Jasvitha Mandava, Vasudha Dadı. Analytical Method Development and Validation for Nirogacestat Using UV Spectrophotometry. HUJPHARM. 2026 Sep. 1;46(3):233-40. doi:10.52794/hujpharm.1789440