Volume 9, Issue 1, January 2019

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A New Simple Method Development, Validation and Forced Degradation Studies of Empagliflozin By Using RP-HPLC

Author(s): V. Shirisha*, Bolle Krishnaveni, Santosh Illendula, K.N.V. Rao, and H. Rajeswar Dutt
Abstract: A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Empagliflozin in bulk and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5μm, 15cm x 4.6mm i.d. column with UV detection at 228 nm and Phosphate Buffer: Acetonitrile = 45:55 (pH-2.8) at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Empagliflozin in bulk and pharmaceutical dosage form. The method was linear over the range of 0–50 μg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.07 μg/ml and quantification was found to be 0.21μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.
PAGES: 25-35  |  86 VIEWS  103 DOWNLOADS

How To Cite this Article:

V. Shirisha*, Bolle Krishnaveni, Santosh Illendula, K.N.V. Rao, and H. Rajeswar Dutt. A New Simple Method Development, Validation and Forced Degradation Studies of Empagliflozin By Using RP-HPLC. 2019; 9(1): 25-35.