Rp-HPLC method development and validation of finerenone in bulk drug and its formulations
Kai yashodabai dagadu saraf charitable trust, college of pharmacy, sakegaon. Kaviyatri Bahinabai Chaudhray North Maharashtra University, Jalgaon, India.
Research Article
GSC Biological and Pharmaceutical Sciences, 2024, 27(01), 214–222.
Article DOI: 10.30574/gscbps.2024.27.1.0128
Publication history:
Received on 02 March 2024; revised on 13 April 2024; accepted on 16 April 2024
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.
Keywords:
Finerenone; Chronic Kidney Disease; Validation; High performance liquid chromatography; KERENDIA
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