Quality by Design Based Development and Quantification of Telmisartan and Rosuvastatin Calcium Using RP-HPLC

Abstract

RP-HPLC technique to estimate the Telmisartan and Rosuvastatin Calcium, employing an experimental design method using response surface methodology, was developed and validated. Experimental design was used to evaluate a multivariate optimisation of experimental conditions using flow rate, buffer pH, and % of acetonitrile in the mobile phase as three independent variables. The peak symmetry and retention time of the last eluting peak were optimized employing Derringer’s desirability function in which 1 ml/min flow rate, KH2PO4 buffer with pH 3.5 (altered with 1% orthophosphoric acid), and 65% v/v of acetonitrile in the mobile phase in an isocratic proportion of acetonitrile: buffer (65:35, v/v) on a C18 column. Using response surface methodology, a RP-HPLC method was developed based on DoE that resulted in a better separation of peaks with a lower retention time of less than 9 min for eluted peaks. Response of linear was reported over the range of concentration of 20-100 μg/mL for Telmisartan and 5-25 μg/ mL for Rosuvastatin Calcium.