Abstract

Background: A reversed-phase high-performance liquid chromatographic method is developed for quantitative analysis of methylprednisolone sodium succinate (MPSS) in nanoparticles.

Method: An ACE 5AQ column (4.6 × 210 mm, 5 µm, Advanced Chromatography Technologies) was used as stationary phase and phosphate buffered saline (PBS, pH 7.4): acetonitrile (70:30 v/v) at a flowrate of 1.5 mL min^-1 was used as mobile phase. The retention time of MPSS was around 5 min. The UV detection was performed at 243 nm. The proposed method was precise, accurate, and linear over the concentration range of analysis (1-100 µg mL^-1, R²=0.9999) with a limit of detection and a limit of quantification of 0.03 and 0.12 µg mL^-1, respectively.

Result: No interference was observed from the nanoparticle formulation ingredients. The method validated was applied for the analysis of MPSS in-vitro release samples of polycaprolactone (PCL) nanoparticles.

Keywords: Methylprednisolone sodium succinate, HPLC, validation, nanoparticles, pharmaceuticals.

Graphical Abstract