Validated Stability Indicating RP-HPLC Method for the Forced Degradation Study of Empagliflozin.

Abstract

To expand an easy to use, available, reliable, and retable RP-HPLC method for determining the formulation and pure form of empagliflozin. Using an isocratic C18 reverse column (250 x 4.6 mm, particle length: 5 µm) with an ammonium acetate and acetonitrile (62:38 v/v) cell section, the method operates at a drift fee of 1ml/minute at a detection wavelength of 265 nm. Empagliflozin within the gift of deterioration merchandise as fast, economic, and dependable products. Forced degradation examine for acid, alkali, oxidation, picture stability, dry warmth, and impartial degradation. Empagliflozin and had measured retention times of 5.3 minutes each. The percentage recoveries of Empagliflozin have been 98.24% respectively. It became discovered that the assay's relative general deviation for empagliflozin was much less than 2%. The correlation coefficient for empagliflozin became determined to be 0.998. The limits of detection and quantification for empagliflozin had been 4.14 ng/ml and 12.55 ng/ml, respectively. For the motive of estimating empagliflozin, a completely unique, quick, sensitive, and solid RP HPLC method changed into evolved and validation changed into performed according with ICH guidelines.