Abstract

QBD APPROACH TO HPLC METHOD DEVELOPMENT AND VALIDATION OF POLMACOXIB IN PHARMACEUTICAL DOSAGE FORM

*S. Raveena, Dr. M. Vishal and T. Devanshi

ABSTRACT

An experimental strategy using Central Composite Design (CCD) was applied via Design Expert software (Version 13.0) to optimize chromatographic parameters for the development of a rapid and reliable HPLC method to quantify polmacoxib in tablet formulations. Contour plots and 3D response surface graphs were generated to evaluate the influence of key variables—flow rate and mobile phase composition—on critical responses such as retention time, theoretical plate count, and tailing factor, with a minimal number of experimental runs. The finalized HPLC method produced well-defined peaks using a YMC C18 column (150 mm × 4.6 mm, 5 µm), with an isocratic elution consisting of Buffer:Methanol in a 30:70 (v/v) ratio at a flow rate of 0.8 mL/min. Detection was carried out at 230 nm. Method validation confirmed good linearity over a concentration range of 10–30 µg/mL \for polmacoxib, showing a strong correlation coefficient. Accuracy was supported by excellent analyte recovery through the standard addition method. This validated method was subsequently applied for the routine estimation of polmacoxib in tablet dosage forms.

Keywords: Polmacoxib, RP-HPLC, Quality by Design, Method Validation, Central Composite Design, ICH Guidelines.