A simple, selective, linear, precise and accurate HPLC method was developed and validated for the estimation of Gliclazide in Gliclazide tablets prepared using natural super disintegrant by direct compression method. Isocratic elution at a flow rate of 1.0 mL/min was employed on HiQSil C18 (250 mm × 4.6 mm, 5 µm) column at ambient temperature using Methanol: Phosphate Buffer 60:40 (v/v) as mobile phase. The UV detection wavelength was carried out at 210nm. The linearity of the developed method was studied over the concentration ranges between 10-30µg/ml. The retention time for Gliclazide was 3.2 min. The developed method was validated as per the ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. The Minimum concentration level at which the analyte can be reliable detected (LOD) and quantified (LOQ) were found to be 0.54 and 1.15 µg/ml respectively. The proposed method can be successfully applied for the estimation of Gliclazide in pharmaceutical dosage forms.
HPLC, Gliclazide, Diabetes, Methanol: Phosphate Buffer
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