A new analytical method development and validation for the determination of teriflunomide in bulk form and marketed pharmaceutical dosage form

Abstract

A rapid, simple, sensitive, precise and cost effective RP-HPLC method was developed and validated for the determination of Teriflunomide in bulk form and marketed Pharmaceutical Dosage Form. The method involved determination of Teriflunomide by resolving on RP-HPLC using Symmetry ODS RP C18, 5mm, 15mmx4.6mm i.d.reverse‐phase column, utilizing a mobile phase of ACN : Methanol: 0.1% Ortho Phosphoric Acid in the ratio of 50:40:10v/v/v. Mobile phase was delivered with isocratic flow rate of 1.0 ml/minute. Ultra violet detection was carried out at 232nm simultaneously over the concentration range of 6-14µg/ml for Teriflunomide. Separation was completed within 6 minutes. The mean recoveries were found to be 99.887 ± 0.654 % w/w for Teriflunomide. The coefficient (r2) was 0.9989 for Teriflunomide. The LOD and LOQ were found to be 0.08µg/ml and 0.24µg/ml for  Teriflunomide  respectively.  The  assay  percentage  of  the  marketed  formulation  calculated  was  99.79  (±0.247)  for Teriflunomide and intra-day and inter-day precision data were found to be <2 %RSD. Developed method was simple, rapid, accurate, precise, reliable, and economical and it can be used for routine analysis for quantitative estimation of Teriflunomide component in bulk form and marketed Pharmaceutical Dosage Form.