Development and Validation of HPLC Method for the Simultaneous Determination of Dexamethasone sodium phosphate and Prednisolone acetate in Injectable Veterinary Suspension

Abstract Dexamethasone sodium phosphate and prednisolone acetate are corticosteroids, both the drugs are available in a veterinary injectable suspension dosage form as DMSP 3.291 mg per ml and PA 7.923 mg per ml. The chromatographic separation was carried out on a reversed-phase C18 column (250mm X 4.6 mm, 5µm) in isocratic mode using acetonitrile: phosphate buffer 0.1% (50:50), at pH 3.0 adjusted with diluted orthophosphoric acid as the mobile phase at a flow rate of 1.0 ml/min. Retention times of DMSP and PA were 2.25 min and 4.50 min respectively. Quantification was carried out with UV detector at 254 nm. The linearity of DMSP and PA was in the range of 10.528µg/ml-23.1616µg/ml and 13.392µg/ml-24.106µg/ml respectively. A simple high-performance chromatography method was developed to the simultaneous determination of dexamethasone sodium phosphate and prednisolone acetate. The developed method is economical in terms of the time taken and the amount of solvents consumed for each analysis. The method was validated as per ICH and successfully applied to the simultaneous determination of dexamethasone sodium phosphate and prednisolone acetate in bulk and pharmaceutical dosage forms.

Keywords Dexamethasone sodium phosphate; Prednisolone acetate; RP-HPLC; Validation.

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Updated: January 20, 2024 — 7:53 am