QBD-DRIVEN STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NINTEDANIB ESYLATE

SANJAY DINKAR SAWANT; JYOTI BHAGWAN TANGDE

doi:10.22159/ijap.2025v17i2.53110

Authors

SANJAY DINKAR SAWANT Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Pune, Maharashtra, India
JYOTI BHAGWAN TANGDE Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Pune, Maharashtra, India

DOI:

https://doi.org/10.22159/ijap.2025v17i2.53110

Keywords:

Degradation, Design expert, Factorial design, ICH guidelines, Nintedanib esylate

Abstract

Objective: The present research work focuses on evaluation of Nintedanib esylate (NTB) with development and validation of Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method pertaining to quality by design-based force degradation study.

Methods: A two-level, two-factorial design has been used with predetermined design specifications using design expert software. The RP-HPLC method was developed with isocratic mode using a C-18 column at a 392 nm detection wavelength.

Results: The calibration curve was found to be linear with R² = 0.9996. Retention Time (RT) was obtained at 6.14; Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found to be 1.4121 μg/ml and 4.2790 μg/ml, respectively. Relative Standard Deviation (RSD) for intraday precision was 1.799% and for interday precision 1.563%, respectively. Degradation studies found out the drug is susceptible to acidic, oxidative, and photolytic conditions, while the drug was found to be stable in thermal and alkaline conditions.

Conclusion: The resulting method holds potential for application in routine analysis of nintedanib esylate in capsule formulation in compliance with International Council for Harmonization (ICH) guidelines.

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