Introduction:
This paper presents the development and validation of a novel, fast, sensitive
and accurate high performance liquid chromatography (HPLC) method for the simultaneous quantitative
determination of dibucaine HCl, fluocortolone pivalate and fluocortolone caproate in pharmaceutical
preparations.
Experiment:
Development of the chromatographic method was based on an experimental design approach.
A five-level-three-factor central composite design requiring 20 experiments in this optimization
study was performed in order to evaluate the effects of three independent variances including mobile
phase ratio, flow rate and amount of acid in the mobile phase.
Conclusion:
The optimum composition for mobile phase was found as a methanol:water:acetic acid
mixture at 71.6 : 26.4 : 2 (v/v/v) ratio and optimum separation was acquired by isocratic elution with a
flow rate of 1.3 mL/min. The analytes were detected using a UV detector at 240 nm. The developed
method was validated in terms of linearity, precision, accuracy, limit of detection/quantitation and solution
stability and successfully applied to the determination of dibucaine HCl, fluocortolone pivalate and
fluocortolone caproate in pharmaceutical topical formulations such as suppositories and ointments.
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