Development and Evaluation of Robust RP-HPLC Method for Gliclazide Estimation Integrating Box Behnken Design

A selective, precise and accurate RP-HPLC method was developed and validated for rapidly determining the quantity of gliclazide in pharmaceutical dosage form. Isocratic elution was employed on a PhenomenexC18 column at a flow rate of 1.2 ml/min. The mobile phase consisted of methanol and 0.02 M potassium dihydrogen orthophosphate (70:30 %v/v). Gliclazide was detected at 210 nm wavelength using UV detector. Linearity was observed in concentration range of 1-100 µg/ml. Retention time of gliclazide retention time was found to be 6.06 min. Validation of developed method was performed as per the ICH guideline. Experimental design approach was used for confirmation of robustness by using Box-Behnken Design with a total 17 runs. The newer method is found to be promising for the estimation of gliclazide in unit or bulk pharmaceutical dosage form.