DEVELOPMENT OF FORCED DEGRADATION STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF FEXINIDAZOLE IN MARKETED FORMULATION
Alaka Kumarawat, Sushma Somkuwar, Rajesh Gour, Akhlesh Kumar Singhai
ABSTRACT
The development of a forced degradation stability-indicating method using High-Performance Liquid Chromatography (HPLC) for the estimation of Fexinidazole in marketed formulations is presented. This study aims to assess the stability of Fexinidazole under various stress conditions and establish a reliable HPLC method for its quantification. System suitability parameters were optimized, resulting in high theoretical plates (2547.840±8.397), a favorable tailing factor (1.177±0.025), and consistent retention time (4.576±0.012). Linearity was demonstrated over a concentration range of 5-25 ?g/ml with a correlation coefficient (r²) of 0.999. Recovery studies confirmed accuracy with mean recovery rates close to 100% at different concentration levels. Precision and robustness tests showed the method to be reliable and consistent, with low variability. The limits of detection (LOD) and quantification (LOQ) were 0.15 mg/ml and 0.45 mg/ml, respectively, indicating high sensitivity. Analysis of tablet samples yielded an assay of 99.80% with minimal variability. Forced degradation studies revealed that Fexinidazole is relatively stable under oxidative and thermal conditions but exhibits significant degradation under acidic and alkaline conditions. This HPLC method is effective for routine quality control and stability testing, ensuring the safety and efficacy of Fexinidazole in marketed formulations throughout its shelf life.
[Full Text Article]