Simultaneous determination of moxifloxacin và dexamethasone in ophthalmic solution by a HPLC method

Van Bach Nguyen, Van Anh Cao, Thi Hong Van Nguyen

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Abstract

The current study focuses on developing and validating a high-performance liquid chromatography (HPLC) method for quantifying moxifloxacin HCL (MOX) and dexamethasone phosphate (DEX) in ophthalmic solution. As a result, MOX and DEX in the eye drop form were determined simultaneously using a HPLC technique with the reverse phase LunaR C18 (4.0 × 250 mm; 5 µm) column. In the procedure, a gradient program of acetonitrile (MeCN) and phosphate buffer pH 2.5 was used as the mobile phase. The developed method yielded retention times of 11.651 minutes (min) for MOX and 18.657 min for DEX. The reliability of the established technique was validated in compliance with the guidelines of the International Council of Harmonization (ICH). In general, all of the metrics, including specificity, linearity, accuracy, range, and precision, were found to be within the acceptable ranges. Consequently, the methodology was assessed to be simple, precise, cost-effective, and replicable. Hence, the analysis of MOX and DEX in ophthalmic solution can be regularly conducted utilizing this procedure specified for the purpose of quality control.

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References

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