AQbD-driven development of a green RP-HPLC method for nirogacestat with LC-MS structural elucidation.

Jayanthi Sabi, Kanaka Parvathi Kannaiah, Hemanth Kumar Chanduluru, Srinivas Nakka, Samar H Elagamy, Reem H Obaydo

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Article in BMC chemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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6 authors.

Jayanthi SabiDepartment of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM-Medical and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India.

Kanaka Parvathi KannaiahDepartment of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM-Medical and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India. kanakapk@srmist.edu.in.

Hemanth Kumar ChanduluruDepartment of Pharmacy Research, SRM College of Pharmacy, SRM-Medical and Health Sciences, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India. hemanthk@srmist.edu.in.

Srinivas NakkaDepartment of Chemistry, School of Science, GITAM Deemed to be University, Hyderabad, 502329, India.

Samar H ElagamyDepartment of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

Reem H ObaydoDepartment of Analytical and Food Chemistry, Faculty of Pharmacy, Ebla Private University, Idlib, Syria. obaydo.reem@ebla.edu.sy.

Funding

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6 · The paper itself

Abstract

Nirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling. This study aimed to develop a green, stability-indicating HPLC method using an Analytical Quality by Design (AQbD) approach. Critical method parameters, including ethanol percentage, ammonium formate buffer concentration, and flow rate, were optimized through risk assessment and a central composite design to establish a robust design space. The final method employed an ethanol-ammonium formate mobile phase (24.14:75.86 v/v, 0.295 mM, pH 3.2) at 1.0 mL/min, achieving baseline separation of NGT, its process impurities, and degradation products with high efficiency (~ 15,900 plates) and symmetry (tailing factor ≤ 1.1). Validation following ICH Q2(R2) confirmed specificity, linearity (R

Indexed as

Analytical quality by designEco-friendly solventGreen analytical chemistryImpurity profilingNirogacestatStability-indicating method

Identifiers

PMID41668179

DOI10.1186/s13065-026-01738-9

PMCPMC12990555

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.