LEFLUNOMIDE TABLET FORMULATION: DEVELOPMENT AND VALIDATION OF AN RP-HPLC TECHNIQUE

Abstract

Objective: To develop a Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for Leflunomide using rapid, cheap, economical, and less composition of the mobile phase. To validate the method's specificity, linearity, precision, accuracy, robustness, and ruggedness were all validated as per regulatory requirements ICH Q2 [R1] guidelines. Methods: The method employed solving of Development and validation based on the measurement of absorbance at one wavelength, 251 nm, λ max, Inertsil-ODS C18 analytical column (250 x 4.6 mm, 5μ). 1.0 ml/min of a mobile phase consisting of water and methanol (40:60v/v) for Leflunomide tablet formulation. Results: The method showed excellent linear response with correlation coefficient (R2) values of 0.999 for a Leflunomide. The percent recoveries for a drug were found within the acceptance limit of (99.93%–100.34%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. It can be concluded from the results that the present method for validation determination of Leflunomide in tablets is specific, rapid, and simple with good sensitivity. Conclusion: This analytical method is also applicable in ordinary laboratories and also technique may be used to measure the drug and assess the uniformity and purity of the dosage formulation as well as for quality control of commercial Leflunomide tablets.