B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Ajidem, Rajkot, Gujarat, India, 360003
*Corresponding Author E-mail: krupap456@gmail.com
Online published on 25 August, 2021.
The high-Performance Analytical Liquid Chromatography (HPLC) method (AQbD) for routine analysis of Gemfibrozil in dosage form was developed in column C18 using an experimental design. The central composite design (CCD) was adopted in evaluating the responses and robustness of the method. In the project, the combined effect of buffer pH, % organic phase and flow rate, each at five levels, was selected for responses such as retention time and number of theoretical plates, then interpreted and optimized statistically with the help of the surface methodology of response and therefore of the analysis of the constructed models and of the outline graphs was obtained. Acetonitrile: phosphate buffer (pH-4) (59: 41% v/v) as eluent at a flow rate of 1.0ml/min was found to be the optimal condition for obtaining the desired answers.
RP-HPLC, Gemfibrozil, Central Composite Design (CCD), Validation, ICH Q2 Guidelines, AQbD