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Home > Archives > Volume 20, No 11 (2022) > Article

DOI: 10.14704/nq.2022.20.11.NQ66009

Stability Indicating Rp-Hplc Method for Assay of Dexamethasone in Its Formulation

Asha Deepti, Alapati Sahithi


New, simple, reliable, and reproducible stability-indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone in formulation using Agilent 1260 DAD Detector. A non-polar analytical chromatographic column Symmetry Waters C18 (150mm×3.9mm, 5µ), was chosen as the stationary phase. The mobile phase used 3.0 OPA Buffer and Acetonitrile. This RP-HPLC method is also validated for various parameters as per ICH guidelines. The system suitability parameters proved that the method is suitable for quantifying dexamethasone. System suitability parameters were within the limits as indicated by good resolution. The precision was within the acceptance criteria of %RSD, i.e., not more than 2%Accuracy was performed with the concentration ranges 50%, 100%, and 150% and was found to be within the limit. No interference was observed at the main peak Retention time in all stressed conditions. Hence it can be concluded that the proposed method was a good approach for obtaining reliable results and can be used as a quality–control tool for routine analysis of dexamethasone in ophthalmic solutions.


OPA Buffer, Dexamethasone, Accuracy, precision

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