Simple and robust RP-HPLC method development and validation for estimation of simvastatin in self-nanoemulsifying drug delivery system

A simple, advance, highly accurate, rapid, Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the determination of simvastatin self-nano-emulsifying drug delivery system (SNEDDS). RP-HPLC method was developed by using a C-18 reverse-phase column (Nucleodur C18, 250 mm×4.6 mm i.d.,5µ). Acetonitrile and water were used in the ratio of 90:10 v/v as a mobile phase. The flow rate was set at 1 mL/min. The response measured wavelength at 238 nm detected by Photo Diode Array (PDA) detector. The retention time was to be found 8.106 min. The developed method was found to be a linear in the range of 2-10 µg/mL with R2 of 0.999. The method was validated as per ICH Q2 (R1) guidelines. The % mean recovery was determined between 95 to 105 % indicating the accuracy development. The relative standard deviation was determined to be less than 2%, indicating that the procedure was also precise. The limits of detection (LOQ) and quantification (LOD) were determined to be 0.52 µg/mL and 0.17 µg/mL, respectively. Developed RP-HPLC method is used to determine the solubility of drug in various oils, surfactants and co-surfactants for formulation of SNEDDS and % drug loading also calculated by this method.