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PHARMASPIRE - Volume 15, Issue 02, 2023, April- June

Pages: 54-60

Date of Publication: 06-Sep-2023

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Development of a validated analytical method for the estimation of sodium fusidate in pharmaceutical dosage form by RP-HPLC

Author: Itishree Jogmaya Das, Tapan Kumar Sahu, Dhiraj Kumar, Himansu Bhusan Samal, Suddhasattya Dey, Alindam Ghosh, Soumik Bhattacharjee, Aliviya Das, Anjan Mondal

Category: Pharmaceutics


Introduction: The determination of sodium fusidate in pharmaceutical dose form was accomplished using a straightforward reverse-phase (RP) high-pressure liquid chromatography (HPLC) approach. The separation through chromatography was accomplished by isocratic elution, on Waters e2695 HPLC system with Empower-3 software and 2998 module Photo Diode Array detectors configured with a pump that delivers quaternary solvents, an automated sample injector, and a column thermostat. A validated RP-HPLC method that is reproducible, rapid, simple, precise, rugged, economical, and accurate has been developed.
Materials and Methods: Separation succeeded using a Thermo Scientific Hypersil ODS (C18) Column (150 × 4.6 mm i.d. and 5 μm particle size), and methanol: 1% V/V glacial acetic acid: acetonitrile used as mobile phase in ratio of 10:30:60% v/v/v, respectively. Ultraviolet detector was used to detect the separation at a wavelength of 235 nm with 1.1 mL/min of flow rate and volume of injection of 20 μL was maintained during the elution with 10-min run time.

Results: It was estimated that the retention time was 5.597 min with a correlation coefficient of 0.999, the anticipated separation was found to be linear in the concentration range of 25–150 mcg/mL and it was found out that according to ICH regulations, every validation parameter fulfilled the acceptance criteria.

Conclusion: Validation of the chromatographic method was done for linearity, specificity, accuracy, precision, robustness, system suitability, limit of detection, and limit of quantification study that it can be utilized for sodium fusidate routine analysis in accordance with ICH recommendations.

Keywords: Isocratic elution, Method validation, Reverse-phase high-pressure liquid chromatography, Sodium fusidate

DOI: 10.56933/Pharmaspire.2023.15110



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