Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form

  • Sonalika Patro Department of Pharmaceutical analysis, Ratnam institute of pharmacy, Pidathapolur, Nellore.
  • S. Harshith Kumar Department of pharmaceutical analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, 524348.
  • M. Barath kumar Department of pharmaceutical analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, 524348. https://orcid.org/0000-0002-9997-204X
  • E. Masthaniah Department of pharmaceutical analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, 524348.
  • K. Sairam Department of pharmaceutical analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, 524348. https://orcid.org/0000-0002-8869-4849
  • S. Prem Sumanth Kumar Department of pharmaceutical analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, 524348. https://orcid.org/0000-0001-7046-4335
Keywords: RP-HPLC, Xterra C18 column, Flucloxacillin sodium, system suitability parameters, ICH guidelines, routine guidelines

Abstract

A Simple, accurate and precise method was developed and validated for the determination of flucloxacillin sodium in its tablet dosage form. The separation was eluted on xterra c18 column (4.6x150mm, 5micron) using a mixture of octane buffer and methanol as mobile phase in a ratio of (30:70) which was pumped through column at a flow rate of  1ml/min. Optimised wavelength for flucloxacillin was 237nm, the retention time was 2.305minutes and the percentage purity was found to be 98.14%. System suitability parameters such as theoretical plate and tailing factor for flucloxacillin sodium was found to be 2991.64 and 1.90 respectively, the proposed method was validated as per ICH guidelines (ICH, Q2 AND (R1)) the method was found to be linear at the concentration range of 20-100µg/ml and the correlation coefficient (r2) value was found to be 0.9994 percentage RSD for precision was 0.9% and percentage RSD for ruggedness was 0.5%. The precision study was precise, robust and repeatable. The LOD and LOQ values are 2.98 and 9.98 respectively. Hence the suggested RP-HPLC method can be used for routine analysis for flucloxacillin sodium in tablet dosage form.

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References

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Published
31-08-2020
How to Cite
Sonalika Patro, S. Harshith Kumar, M. Barath kumar, E. Masthaniah, K. Sairam, & S. Prem Sumanth Kumar. (2020). Stability indicating RP-HPLC method for the estimation of flucloxacillin sodium in a tablet dosage form. International Journal of Research In Pharmaceutical Chemistry and Analysis, 1(4), 95-100. https://doi.org/10.33974/ijrpca.v1i4.205
Section
Research Article