Research Articles

2022  |  Vol: 8(1)  |  Issue: 1(January-February)  |  https://doi.org/10.31024/ajpp.2022.8.1.4
RP-HPLC method development and validation for the estimation of Sofalcone in bulk drug and formulations with forced degradation studies

Dharati Rami1*, Nehal J. Shah2, Ankit Chaudhary3

1Ph. D. Section, Gujarat Technological University, Gujarat 382424, India https://orcid.org/0000-0002-2314-4205

2Indubhai Patel College of Pharmacy and Research Centre, Gujarat Technological University, Gujarat 382424, India

3Saraswati Institute of Pharmaceutical Sciences, Gujarat Technological University, Gujarat 382424, India 

*Address for Corresponding Author

Dharati Rami

Department of Quality Assurance, Gujarat Technological University, Gujarat 382424, India https://orcid.org/0000-0002-2314-4205,

 

Abstract

The current study was to develop a simple, accurate, precise, reproducible and economic reverse phase HPLC method for Quantification of sofalcone in bulk drug as well as in formulations.  The method development can be achieved by C 18 column (150x4.6 mm and 5µm particles) was used for the estimation of Sofalcone using 0.1 M Ammonium acetate buffer with 1 ml tiethylamine (pH 5.6) and acetonitrile in a ratio 50:50%v/v as mobile phase and  at ambient temperature and the detector was set at wavelength 348nm. ICH guidelines were followed for method validation. Forced degradation studies were also done by exposing the drug to different stress conditions (Photolytic, thermal, acidic, alkaline, and Oxidative). The developed validated method was also utilized to quantify the Sofalcone in the marketed formulation successfully. The method was found linear within the range of 50-150 µg/mL with LOD of 0.028 µg/mL and LOQ of 0.087µg/mL whereas recovery was found within the range of 100.02% -100.55%. Method was found to be able to distinguish the parent drug from degraded products and quantify Sofalcone in Dosage form (100.91%). A linear, robust and economic RP-HPLC method was developed with LOD and LOQ within the good range which can be adopted for the routine analysis of Sofalcone in bulk drugs and formulations.

Keywords: Sofalcone, HPLC, validation, stability

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