QbD Approach in RP-HPLC Method development for the Assay of Benzocaine and Diclofenac in dosage forms

摘要

The present study was conducted to determine simultaneous various response optimization with the help of Derringer's desirability function. Using the optimization HPLC method development was done to detect Benzocaine andDiclofenac in the marketed pharmaceutical formulation. Liquid chromatography using C_(18)column was used with Central Composite design for the study. DoE is a tool for the optimization of composition parameters. It is utilized for the evaluation of principal effects along with their interactions. CCD is a part of RSM which shows quadratic response surfaces without a three level factorial design. Twenty experiments along with 5 center points were studies with three factors for BEN and DIC in A: Content of Acetonitrile in mobile phase (% w/w), B: Flow rate (ml/mins), C: pH.The factor space was increased within the range of Acetonitrile concentrations from 55-65 % v/v, pH 3 - 4, Flow rate change 0.8 - 1.2 ml/min, the capacity factor for peak of benzocaine, (k_1), the retention time of Diclofenac(tR_2), Resolution of the critical separated peak, Benzocaine and Diclofenac, (Rs_(1,2)) were used as responses. The resolution between peak (Rs_(1,2)) were found to be greater than 1.5 in the preliminary study. Therefore, these 2 peaks are critical peaks and utilized as response for global optimization. Predicted contour data for Rtwas verified and it satisfies with experimental data.