STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NELFINAVIR MESYLATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

The chromatographic conditions were successfully developed for the separation of Nelfinavir Mesylate by Agilent C18 Column (250mm x 25mm)5µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer (90:10 v/v), detection wavelength was 251 nm. The Spectroscopic method was done in solvent using mobile phase and the instrument Systronics 1170 with UV win software. The instrument used was Agilent HPLC, Separation module 2695, Uv-Vis detector, Empower-software version 2. The retention time was found to be 5.233 min. The % purity of Nelfinavir Mesylate was found to be 98.14%. The system suitability parameters for Nelfinavir Mesylate such as theoretical plates and tailing factor were found to be 11519, 1.04. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Nelfinavir Mesylate using internal standard was found in concentration range of 0.1µg-10 µg and correlation coefficient (r2) was found to be 0.9996 respectively, % recovery was found to be 100.02% respectively. %RSD for repeatability and precision was found to be <2. LOD value was 80 ng/mL and LOQ value was found to be 100 ng/mL respectively for Nelfinavir Mesylate