Determination of RP-HPLC Method for Safinamide: Its Bulk and Tablet Dosage Form

Abstract

A new method was established for estimation of Safinamide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Safinamide by using Agilent C18 column (4.6×150 mm, 5 µ); flow rate was 1 ml/min, mobile phase ratio was Methnol, Acetonitril (60:40), pH 3 (pH was adjusted with orthophosphoric acid), detection wavelength was 235 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.305 min. The % purity of Safinamide was found to be 99.54%. The system suitability parameters for Safinamide such as theoretical plates and tailing factor were found to be 4600 and 1.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Safinamide was found in a concentration range of 5–25 µg and correlation coefficient (r²) were found to be 0.998, % recovery were found to be 99.48%, %RSD for repeatability was 0.17, % RSD for intermediate precision was 0.1. LOD value was 0.303 and LOQ value was 1.011. Hence the suggested RP-HPLC method can be used for routine analysis of Safinamide in API and pharmaceutical dosage form.

Keywords: Safinamide, RP-HPLC

Cite this Article

Godasu SK, Rajashakar V, Jyothi GSVD, et al. Determination of RP-HPLC Method for Safinamide: Its Bulk and Tablet Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2018; 5(3): 1–6p.