A new validated facile HPLC analysis method to determine methylprednisolone including its derivatives and practical application.

Methylprednisolone sodium succinate (MPSS) is a parenteral water-soluble corticosteroid ester. It gives three peaks methylprednisolone (MP), 17-methylprednisolone hemisuccinate (17-MPHS), and methylprednisolone hemisuccinate (MPHS) that share in the assay determination as total MP. It is used on a wide scale in prescribed anti-inflammatory drugs as a common use. The current study aimed to find a rapid RP-HPLC method of MP and its derivatives analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive to use without the need for any special chemical reagents. The use of the current method achieved a satisfactory result to detect, determine and separate the MP, 17-MPHS, and MPHS in a short time. The chromatographic system consists of RP-HPLC using the BDS column (250 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing the WFI: glacial acetic acid: acetonitrile in a volume ratio (63:2:35) at a flow rate of 2.0 mL/min with detection wavelength at 254 nm at room temperature and injection volume 20 μL. The method manifested a satisfied linearity regression R (0.9998-0.99999) with LOD 143.97 ng/mL and 4.49 µg/mL; and LOQ 436.27 ng/mL and 13.61 µg/mL for MP and MPHS respectively. The method proved its efficiency via system suitability achievement in the robustness and ruggedness conduction according to the validation guidelines. High sensitivity according to its LOD and LOQ. So, the current method could be considered in the pharmaceutical industry. The suggested method has been successfully implemented in the Egyptian local market for the quantitative assessment of the assay of the finished product.