RP-HPLC Method Development And Validation Of Glipizide And Glibenclamide In Bulk And Pharmaceutical Dosage Form

Abstract

A precise and robust method was developed for estimation of Glipizide and Glibenclamide in bulk and formulations by RP-HPLC technique. The Method used Agilent 1260 Infinity II model HPLC with DAD detector and Agilent Zorbax Bonus RP Column with dimension 250 x 4.6 mm, 5 mm. The Mobile phase combination used was 0.1% Trifluoroacetic acid (TFA) and Methanol (30:70), flow rate at 1.0 ml/min and wavelength at 211 nm with run time of 15 minutes. The retention time of Glipizide and Glibenclamide peaks were at 4.91 and 9.45 minutes, respectively. The method was validated as per ICH guidelines. The instrument precision for Glipizide and Glibenclamide had a %RSD of 0.08% and 0.13%, respectively. Method was linear and accurate for concentration range 40-60mg/ml for both Glipizide and Glibenclamide with regression coefficient of 0.9994 and 0.9997, respectively. % RSD for accuracy for Glipizide at 80%, 100% and 120% was found to be 0.30%, 0.05% and 0.07%, respectively; and for Glibenclamide at 80%, 100% and 120% was found to be 0.56%, 0.16% and 0.11% respectively.