Development of Validated Stability Indicating HPTLC Method for Estimation of Febuxostat in Bulk and Tablet Dosage Form by Using QBD Approach

Abstract

Objective: Development of a simple, reliable, time-tested, stability-focused HPTLC method for determining febuxostat (FEB) in bulk and pharmaceutical formulation. Methods: Chloroform, methanol, and formic acid (6.7:2.9:0.1v/v/v) served as the mobile phase, and precoated aluminum TLC plates served as the stationary phase. Active drug FEB was subjected to a densitometric measurement (absorbance mode at 312 nm). The present study performed a comprehensive stress test of FEBas per ICH Q1A(R2) guidelines. FEB has undergone forced degradation by acid, alkali (0.5N HCl and NaOH), oxidative (3% H2O2), H2O and photolytic effect. Results: Calibration plots using HPTLC linear regression analysis indicated a strong correlation (r2 = 0.999) between concentrations from 150 to 900 ng/spot. Accuracy, recoverability, robustness, and documentation are some of the aspects of the method that have been verified. The LoD was 189 ng and the LoQ was 395 ng per location. FEB was not degraded under acid, UV, water, peroxide and photolytic conditions but showed degradation under alkaline conditions. Conclusion: Stability studies and quantification of FEB in bulk and pharmaceutical dose forms by QBD methodology have both been shown to benefit from the suggested HPTLC method. This technique can be utilized as a stability indicator because it successfully isolates the medication from the degradation product.