Stability Indicating Analytical Technique Development and Validation for the Determination of Fexinidazole in Bulk and Dosage Form Utilizing RP-HPLC

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DOI:

https://doi.org/10.26452/fjphs.v2i4.321

Abstract

Actual HAT therapy decisions were unexpected, poisonous, and ineffectual, rather than truly difficult, versus distributing mainly within the condition's afterward but rather life-threatening stages (stage 2, chronic HAT). Pharmaceuticals that are safe, effective, and straightforward to use were also critical. Fexinidazole is just a 5-nitroimidazole that has been investigated in such a therapeutic efficacy test as an oral for the said role in human African reflect the difference. A positive stability-indicating RP-HPLC attitude is already developed and implemented to recognize and classify Fexinidazole along tablet but rather bulk oral dosage structures. A chromatographic evaluation was performed on every excellent lake c18 column 250 mm X 4.6 mm x 5 µ, including an isocratic fluid. The phosphate buffer pH 2.5 adapted to HCL 0.1 N: methanol 60: 40 v/v at even a flow rate after all 0.8 ml/min or eluents were surveilled about 226 nm. A posited method's precision, pinpoint accuracy, high precision, flatness, and rather resiliency were ascertained throughout compliance with the application and the ICH proposals. Repeated dose toxicity investigations have confirmed this same method's consistency marker function. Hydraulic retention, such as Fexinidazole, seemed to be 4.07 minutes. That whole novel technique must've been reviewed, such as stationarity and precision, but instead, accuracy. Consequently, its proposed RP-HPLC reach, such as quantifying Fexinidazole, seems to have been indicated to be trustable, constant, accurate, or sensitive.

Keywords:

African Trypanosomiasis, Sleeping Sickness, Fexinidazole, Methanol, ICH Guidelines

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Published

2022-10-07

How to Cite

Sudheer Kumar H M, & Kothapalli Bannoth Chandrasekhar. (2022). Stability Indicating Analytical Technique Development and Validation for the Determination of Fexinidazole in Bulk and Dosage Form Utilizing RP-HPLC. Future Journal of Pharmaceuticals and Health Sciences, 2(4), 293–300. https://doi.org/10.26452/fjphs.v2i4.321

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Original Articles