Development and Validation of a precise single HPLC method for the determination of Dexamethasone in API and Pharmaceutical dosage form

Volume 20 No 22 (2022)

Neelesh Chaubey, Jayesh T. Nimbalkar and Gautam P. Vadnere

DOI: 10.48047/nq.2022.20.22.NQ10489

Abstract

A novel, sensitive, stability-indicating HPLC method has been developed for the quantitative estimation of dexamethasone-related impurities in both bulk drugs and pharmaceutical dosage forms. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on RP Phenomenex Gemini C18 (250 mm x 4.6 mm I.D.) with particle size 5 µm and mobile phase 0.1% orthophosphoric acid: acetonitrile (60:40 v/v) was selected. It exhibited linearity over the concentration range of 2-14 µg/mL with limit of detection of 0.282 mg/mL The drug content was found to be 99.608. The present successfully validated method with excellent selectivity, linearity, sensitivity, precision and accuracy was applicable for the assay of dexamethasone in bulk drug substance and pharmaceutical dosage forms.

Keywords

Dexamethasone, Validation, Tablets, Bulk, RP-HPLC

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