000			01600nam a2200145 4500
008			250821b |||||||| |||| 00| 0 eng d
100			_aMukesh P. Ratnaparkhi
245			_aRP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF REMDESIVIR IN IV FORMULATION
300			_a Page No. 45-49
520			_aThe overall effect of the SARS-CoV-2 virus, instigating COVID-19, has highlighted the urgent need for effective treatments. Remdesivir, the only FDA-approved antiviral for severe COVID-19 in adults and children, requires precise analytical methods for its pharmaceutical formulation. Current HPLC techniques exist, but there is a critical demand for more efficient and accurate approaches. The current study addresses this need by developing and validating a specific HPLC method for quantitative analysis in an IV dosage form for remdesivirs. Utilizing a C18 column with a 0.7 mL min- ¹ flow rate, the analysis was completed in 10 minutes with an isocratic mobile phase of 50:50 V/V acetonitrile and methanol. Validation followed ICH Q2 (R2) guidelines, confirming the method's suitability, linearity, precision, accuracy and robustness. The results indicate that this HPLC method is straightforward, efficient and highly sensitive, making it a valuable tool for ensuring the quality and efficacy of remdesivir.
654			_aCOVID-19 _aRP-HPLC _amethod development and validation _aremdesivir _aquantification
700			_a Avinash R. Tekadea
773	0		_0125265 _9113416 _dMumbai Indian Drugs Manufacturer's Association _tIndian Drugs _x0019-462X
942			_cJA
999			_c132520 _d132520