Development and Validation of a Green UPLC Analytical Procedure for Glibenclamide Determination in Pharmaceutical Product Using Response Surface Methodology

Glibenclamide (GB) is one of the drugs that used in first line for management diabetes mellitus. The aim this work to develop a unique green UPLC analytical procedure analyze GB pharmaceutical products by implementing QbD (Quality Design) approach. 32 full factorial design was applied study effect three levels formic acid (X1; 0.05-0.5%) and temperatures (X2; 25-55oC), their effects on retention time (Y1), peak area (Y2), height (Y3), HPLC-EAT; environmental assessment tool (Y4). A mobile phase, which composed Methanol 70% water 30% containing different concentrations acid, pumped Isocratic elution mode at flow rate 0.2 ml/min, with total run 3.0 min UV detection 225 nm. Subsequently, method successfully validated using several validation parameters according ICH guidelines. results showed temperature had significant indirect (P value = 0.001), while concentration impact Peak Area 0.0101). highly affected as well P < 0.005. Furthermore, HPLC-EAT column an way. optimized discovered be acceptable terms selectivity, precision, accuracy, robustness, sensitivity, specificity. Moreover, efficaciously separated presence its degradation harsh conditions, revealing stability-indicating property.