DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF LEFLUNOMIDE IN ITS PHARMACEUTICAL DOSAGE FORM

  • Kavita A Sola Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350
  • Praful P Dedhiya Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350
  • Shailesh A Shah Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Abstract

A specific, accurate, precise and robust HPTLC method has been developed for estimation of Leflunomide in its
pharmaceutical dosage form. The chromatographic separation was performed using Aluminum backed precoated with
silica gel 60F254 as stationary phase and toluene: ethyl acetate: glacial acetic acid (8:2:0.5 %, v/v/v) as mobile phase.
The quantification was carried out at 270 nm wavelength. The method was validated as per ICH Q2 (R1) guidelines.
The Rf value was found to be 0.53 ± 0.02. The linearity of method was satisfactory over the range 25-125 ng/spot
with correlation coefficient of 0.9960.The limit of detection was found to be 1.71 ng. The limit of quantitation was
found to be 5.19 ng. The recovery was found in the range 99.67-100.89%.The method was successfully applied to
marketed formulations of Leflunomide.
 

Keywords: Leflunomide, Estimation, HPTLC.

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Author Biographies

Kavita A Sola, Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Praful P Dedhiya, Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Shailesh A Shah, Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

Maliba Pharmacy College, Bardoli, Gujarat, India - 394 350

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How to Cite
Sola, K. A., P. P. Dedhiya, and S. A. Shah. “DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF LEFLUNOMIDE IN ITS PHARMACEUTICAL DOSAGE FORM”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 4, Dec. 2017, pp. 60-67, doi:10.22270/ijdra.v5i4.210.