Developing and validating RP-HPLC methods to estimate metformin in bulk and tablet dosage forms

Using RP-HPLC technology, a new technique for estimating Metformin was developed. Using a YMC Column (4.6*150mm, 5 microns), the chromatographic conditions for the separation of Metformin were effectively developed. The flow rate was 1 ml/min, and the mobile phase ratio was 50:50 v/v. Orthophosphoric acid was used to modify the pH of the methanol phosphate buffer (KH2PO4 and KH2HPO4) to 3.5. The wavelength of detection was 210 nm. The Waters HPLC Auto Sampler, the photodiode array detector (model 2497), the separation module (model 2695), and the Empower software version 2 were the instruments used. It was discovered that the retention periods were 2.3 and 3.3 minutes. It was found that the purity of Metformin was 100.16% and 100.12%, respectively. With a resolution of 5.75, the system suitability parameters for Metformin, including theoretical plates and tailing factor, were determined to be 4529.07, 1.18, 4633.60, and 1.20. The ICH guidelines (ICH, Q2 (R1)) were followed in the Validation of the analytical method. The linearity investigation revealed that the concentrations of Metformin were between 500 μg and 2500 μg and between 50 μg and 250 μg. The correlation coefficient (r2) was 0.999 and 0.999, and the percentage recovery was 100.43% and 100.50%. The corresponding RSDs for repeatability and intermediate precision were 0.8 and 0.3 and 0.8 and 0.4, respectively. The precision analysis was accurate, reliable, and repeatable. The corresponding LOQ values were 9.98 and 10.00, while the LOD values were 3.02 and 3.00.