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An Improved and Validated HPLC Method for the Determination of Methylprednisolone Sodium Succinate and its Degradation Products in Nanoparticles

[ Vol. 13 , Issue. 2 ]

Author(s):

Yasemin Karabey-Akyurek, Emirhan Nemutlu, Erem Bilensoy and Levent Oner   Pages 162 - 168 ( 7 )

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.

Affiliation:

Department of Analytical Chemistry, Faculty of Pharmacy, Hacettepe University, 06100, Ankara

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