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
Abstract:
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
DOI URL: https://doi.org/10.56933/Pharmaspire.2023.15110
References:
1. Ravisankar R, Navya CN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm 2015;5:7-19.
2. U.S. Department of Health and Human Services. Guidance for Industry Q3B (R2) Impurities in New Drug Products. 2nd ed. Rockville, MD: U.S. Department of Health and Human Services; 2006. p. 1-8.
3. Reynolds DW, Facchine KL, Mullaney JF, Alsante KM, Hatajik TD, Motto MG. Available guidance and best practices for conducting forced degradation studies. Pharm Technol 2002;26:48-54.
4. U.S. Department of Health and Human Services: Food and Drug Administration. Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information. 1st ed. Rockville, MD: HHS-FDA; 2003. p. 1-24.
5. Lloyd R, Joseph J. Practical HPLC Method Development. 2nd ed. New York: John Wiley and Sons Ltd.; 1979. p. 15-745.
6. Rouessac F, Rouessac A. Chemical Analysis: Modern Instrumentation Methods and Techniques. 2nd ed. France: John Wiley and Sons Ltd.; 2007. p. 63-89.
7. Douglas AS. Principles of Instrumental Analysis. 6th ed. USA: Belmont; 2014. p. 816-44.
8. Hikal AH, Shibl A, El-Hoofy S. Determination of sodium fusidate and fusidic acid in dosage forms by high-performance liquid chromatography and a microbiological method. J Pharm Sci 2008;71:1297-8.
9. Shaikh S, Muneera MS, Thusleem OA, Tahir M. A simple RP-HPLC method for the simultaneous quantitation of chlorocresol, mometasone furoate, and fusidic acid in creams. J Chromatogr Sci 2009;47:178-83.
10. Ankam R, Mukkanti K, Durgaprasad S, Naidu P. Development and validation of RP HPLC method for determination of halobetasol propionate and preservative (Methyl paraben and propyl paraben) in formulation. Asian J Chem 2010;22:3369-75.
11. Curbete MM, Salgado HR. Stability-indicating RP-LC method for quantification of fusidic acid in cream. Braz J Pharm Sci 2016;52:447-57.
12. Goswami N, Gupta VR, Jogia HA. Development and validation of a novel stability-indicating RP-HPLC method for the simultaneous determination of halometasone, fusidic acid, methylparaben, and propylparaben in topical pharmaceutical formulation. Sci Pharm 2013;81:505-18.
13. Seal T. Quantitative HPLC analysis of phenolic acids, flavonoids and ascorbic acid in four different solvent extracts of two wild edible leaves, Sonchus arvensis and Oenanthe linearis of North-Eastern region in India. J Appl Pharm Sci 2016;6:157-66.
14. Jakasaniya MA, Shah JS, Maheswari DG. Simultaneous estimation of clobetasol propionate and fusidic acid in cream dosage form by reversed phase high performance liquid chromatographic method. Pharmacophore 2014;5:231-8.
15. Byrne J, Velasco-Torrijos T, Reinhardt R. An RP-HPLC method for the stability-indicating analysis of impurities of both fusidic acid and betamethasone-17-valerate in a semi-solid. J Chromatogr Sci 2015;53:1498-503.
16. Sharma P, Sudhakar P, Shrivastava B. Validation of stability indicating HPLC method for assay of fusidic acid, betamethasone-17 valerate and chlorocresol content in topical pharmaceutical formulation. Int J Pharm Chem Anal 2015;5:102-10.
17. Curbete MM, Salgado HR. A critical review of the properties of fusidic acid and analytical methods for its determination. Crit Rev Anal Chem 2016;46:352-60.
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