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HPLC Method Development, Validation, and Degradation Study of Fosetasmvir by: A Comprehensive Analytical Investigation

Author: Aher B.O., Prakash S. and Bairagi V.A.

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Abstract

This study aimed to quantify Fostemsavir and investigate its breakdown patterns using HPLC and LC-MS techniques. Fostemsavir was obtained as a free sample from Spectrum Laboratory Pvt. Ltd. Solvents and other substances were purchased from S.D. Fine Chemical and the Research Lab. Reliable and precise results were ensured by using high-quality reagents and suitable filtration methods. A Chromatographic Phenomenon C18 column (250 4.6 mm, 5 μm) was employed with a 70:30 methanol: phosphate buffer solvent ratio. UV radiation was used to measure the absorbance of a 10 μg/ml Fostemsavir solution in methanol, with a maximum absorbance observed at 278 nm. The method was validated using ICH standards and demonstrated accurate identification, quantification, and detection of breakdown products. This approach is suitable for routine laboratory analysis and quality control of Fostemsavir.

Keywords

HPLC, Fosetasmvir, Forced degradation, LC-MS, ICH

Conclusion

A validated HPLC method was developed for the quantification of the medication fostemsavir in compliance with ICH criteria. The technique performed satisfactorily for all validation metrics, including system appropriateness, method precision, accuracy, LOD and LOQ, and robustness. This tried-and-true method has many advantages, including shorter run times, cheaper costs, accessibility, good sensitivity, dependability, and reproducibility. The behaviour of the medications' degradation was investigated under a variety of stress conditions, including acid, basic, oxidation, reduction, photolytic, and thermal stress. The medications were shown to be unstable in situations involving acid, alkali, and oxidation, but stable in situations involving reduction, heat, and photolysis. The degradation products were further characterised using LC-MS and FTIR analyses.

References

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How to cite this article

Aher B.O., Prakash S. and Bairagi V.A. (2023). HPLC Method Development, Validation, and Degradation Study of Fosetasmvir by: A Comprehensive Analytical Investigation. Biological Forum – An International Journal, 15(4): 844-853.