A stability indicating RP-HPLC method for related impurities of dexamethasone in tobramycin and dexamethasone otic suspension
Keywords:
Otic, Stability, quantification, thermal, acidic, stress condition, Suspension, USPAbstract
A Stability Indicating RP-HPLC Method for Related Impurities of Dexamethasone in Trobramycin and Dexamethasone Otic Suspension USP 0.3% and 0.1%. 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 the quantification of 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%. Linearity was observed in concentration range of LOQ to 200% and the Correlation coefficient was found to be within the limit. Accuracy was performed with the concentration ranges 50%, 100%, and 200% and was found to be within the limit i.e., 85 to 115%. Stability was evaluated by subjecting the ophthalmic suspension to thermal, acidic, basic, oxidative, and UV stress condition. 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 Trobramycin and Dexamethasone Otic Suspension USP 0.3% and 0.1%.
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