Abstract
I have done research and achieved the method development & validation of highly accurate, sensitive, precise, rapid gradient system RP-HPLC method of finerenone in both bulk drug & pharmaceutical fixed dosage forms. The separation was achieved on (Agilent) C18 column (4.6 mm*250 mm, 5µm) having this configuration with particle size 5µm & using mobile Methanol: 10 Mm Citric Acid with ratio (38:62) having flow rate 1.0 ml/min. Detection of finerenone was carried out at 258nm. The total chromatographic analysis time per sample was about 15min and retention time of overall analysis is 6.9 min. The response exhibited a linear relationship with concentration in range 98-102 mcg/ml for finerenone correlation coefficient is 0.999 and %RSD is 0.126. The method was validated for accuracy, precision, specificity, linearity & sensitivity. Validation studies demonstrated that the method is simple, specific, rapid, reliable & reproducible.
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