RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FEXINIDAZOLE IN BULK FORM
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JSPM’s Rajarshi Shahu College of Pharmacy & Research, Tathawade, Pune-33, Maharashtra, India
Received: 2025-09-23
Revised: 2025-10-07
Accepted: 2025-10-23
Published: 2025-11-04
An RP-HPLC technique with high sensitivity and precision has been devised to accurately determine the concentration of Fexinidazole in its bulk formulation. The maximum wavelength (λmax) of Fexinidazole was determined to be 264 nm in Methanol: Phosphate Buffer 7.4 solution at a ratio of 75:25 % v/v. The approach demonstrates a high level of sensitivity, with a linear range of 2 to 10 µg/ml. The regression equation for this range is y = 203134x + 9713.5, with a r2 value of 0.9997. This approach is validated and tested in accordance with the criteria specified in the ICH guidelines and USP. The detection limit and quantitation limit were determined to be 0.008 µg/ml - 0.02 µg/ml, respectively. The results indicated that the technique is precise, specific, and repeatable, with a relative standard deviation (RSD) of less than 2%. Additionally, the procedure is straightforward, cost-effective, time-efficient, and suitable for determining Fexinidazole in bulk forms.
Fexinidazole, HPLC method, Quantitative Analysis, AMD, Method development.