DEVELOPMENT OF NOVEL SINGLE HPLC METHOD FOR SIMULTANEOUS SEPARATION OF MULTIPLE IMPURITIES IN DEXAMETHASONE DRUG PRODUCT

Objective: A simple, reliable, and rapid HPLC method has been established for the detection of Dexamethasone (DEX) and its related impurities. The proposed method has been validated for specificity, linearity, system suitability, accuracy, precision, robustness, LOD, and LOQ as per International Council for Harmonisation (ICH) guidelines. All parameters were found to be within the accepted limits, affirming the method's reliability. Methods: Analysis was conducted using HPLC on X-Bridge C18 column (250 mm×4.6 mm id, 3.5 µm) with a mobile phase-A comprising buffer and acetonitrile (90:10, v/v), mobile phase-B comprising buffer and acetonitrile (25:75, v/v) and a flow rate of 0.8 ml/min by following gradient elution. The detection was performed with a UV detector set at 240 nm. The method has been employed to investigate DEX and DEX-related impurities. These studies were conducted in tablet formulations of DEX. Results: The Retention Time (tR) of DEX was about 41.589 min, and all parameters met acceptable limit values. The response exhibited linearity over a concentration range of 0.162 to 3.052 µg/ml (R2= 0.9999). The percentage of DEX recovered from the pharmaceutical tablet dosage form ranged from 96.3 % to 100.4 %. Sensitivity levels for the developed method were indicated by LOD and LOQ values of 0.081–0.162 µg/ml. The proposed method was validated according to ICH guideline. Conclusion: Hence, a simple, reliable, accurate, and precise HPLC method was developed, proving suitable for the separation of DEX and DEX-related impurities in commercial formulations.