Method Development and Validation of Fludrocortisone Acetate Tablets by Reverse Phase HPLC Method

The purpose or intent of this current study was to establish a fast and sensitive
HPLC technique for the perseverance of Fludrocortisone acetate and utilizing
best frequently used HPLC technique. This method had been validated as per

the ICH requirements to assure that the method consistently meets the prede-
termined speciθications and quality attributes.Utilizing θiltered and degassed

pH 3.0 Phosphate buffer and Acetonitrile in the ratio 90:10 as a Mobile phase-
A and pH 3.0 Phosphate buffer and Acetonitrile in the ratio 65:35 as a Mobile

phase-B the established RP-HPLC technique was done. The separation was
achieved by using Waters, X-Bridge Shield RP18, (150 X 4.6-mm), 3.5-μmcolumn. Run time and Flow rate was set 45minutes and 1.2mL/min. Injec-tion volume 100μL and wavelength was set 240nm.The correlation coefθicientsquare for θludrocortisones acetate and Fludrocortisone Impurity was foundto be 0.9991 and 0.99997. The SD and %RSD for Fludrocortisone Impurity was