Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin HCl and Gliclazide

A new, simple and validated RP-HPLC method was developed for simultaneous estimation of MetforminHCl (MET) and Gliclazide (GLZ).The separation was achieved by using mobile phase Methanol: 10 mM Phosphate buffer (pH 3) 70:30 % v/v on Kinetics C₁₈ column (250 x 4.6 mm, 5μ). The flow rate was 1 ml/min. The detection was carried out at wavelength 230 nm.The retention time of MET and GLZ was found to be 2.20 min and 4.67 min, respectively. Calibration curves for MET and GLZ were found to be linear in the range of 10-60 μg/ml and 2-12 μg/ml, respectively. The proposed method was validated as per ICH guideline Q2 (R1). The validation parameters studied were linearity, accuracy, precision, specificity and robustness. All validation parameters were found within the acceptable range.