Stability Indicating Related Substances Method Development and Validation of Eplerenone and Torsemide Using Reverse Phase High Performance Liquid Chromatography

Authors

  • Challa S. Reddy Department of Chemistry, Vikas PG College, Vissannapeta, Andhra Pradesh, India
  • Bubathula T. Rao Department of Chemistry, Vikas PG College, Vissannapeta, Andhra Pradesh, India

Abstract

A new simple related substances method was developed and separated its degradation products of Eplerenone and Torsemide using asymmetry C18 column with a flow of 1 mL/min on reverse phase high performance liquid chromatography (RP-HPLC). Using the movable phase of acetonitrile 54 and 0.1% Orth phosphoric acid in gradient mode, Eplerenone, Torsemide drugs, and their impurities were separated. The photo diode array detector was monitored at 261 nm. According to the ICH guidelines, the parameters like system precision, linearity, accuracy, method precision, ruggedness, robustness, stability, Limit of Detection (LOD), Limit of Quantification (LOQ), and the degradation studies were validated and found to be acceptable.

Keywords:

Eplerenone, reverse phase high performance liquid chromatography (RP-HPLC), RS-Method, Torsemide, Validation

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Published

2021-09-08
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Issue

Vol. 12 No. 3 (2021): Volume 12,Issue3

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Articles